Compounds > plecanatide
Page last updated: 2024-11-13

plecanatide

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Description

plecanatide: A uroguanylin analog and guanylate cyclase (GC-C receptor) agonist that activates receptors on gut epithelial cells to maintain barrier function, mucus production, and suppress inflammation. It is used in the treatment of chronic idiopathic constipation and other gastrointestinal disorders. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID70693500
CHEMBL ID2103867
MeSH IDM0589195

Synonyms (28)

Synonym
sp-304 (synergy)
guanilib
CHEMBL2103867
plecanatide
(3-glutamic acid(d>e))human uroguanylin (ugn)
plecanatide [usan:inn]
hsdb 8405
l-leucine, l-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l- cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-, cyclic (4->12),(7->15)-bis(disulfide)
7ik8z952ok ,
unii-7ik8z952ok
trulance
[3-glutamic acid(d>e)]human uroguanylin
gtpl9069
DTXSID60196933 ,
DB13170
asn-asp-glu-cys-glu-leu-cys-val-asn-val-ala-cys-thr-gly-cys-leu cyclic (4->12),(7->15)-bis(disulfide)
l-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l-cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-l-leucine cyclic (4adagger?2),(7adagger?5)-bis(disulfide)
467426-54-6 (free base)
l-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l-cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-l-leucine cyclic (4-->12),(7-->15)-bis(disulfide)
EX-A4131
GLXC-26182
plecanatidum
(3-glutamic acid(d>e))human uroguanylin
a06ax07
dtxcid00119424
plecanatida
trulanceimmediate release
l-leucine, l-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l-cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-, cyclic (4-12),(7-15)-bis(disulfide)

Research Excerpts

Overview

Plecanatide is a pH-sensitive uroguanylin analog that increases fluid and ion movement into the gastrointestinal lumen, softening stools and encouraging motility. It is a well-tolerated treatment that relieved the symptoms of CIC with a relatively low incidence of diarrhea.

ExcerptReferenceRelevance
"Plecanatide is a pH-sensitive uroguanylin analog that increases fluid and ion movement into the gastrointestinal lumen, softening stools and encouraging motility, while limiting the risk of diarrhea."( Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.
Barish, C; Dorn, S; Fogel, RP; Patel, R; Rosenberg, J, 2021)		2.79
"Plecanatide is a well-tolerated treatment that relieved the symptoms of CIC with a relatively low incidence of diarrhea."( Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.
Barish, C; Dorn, S; Fogel, RP; Patel, R; Rosenberg, J, 2021)		3.51
"Plecanatide is an oral guanylate cyclase-C agonist for the treatment of gastrointestinal disorders. "( Liquid-Phase Total Synthesis of Plecanatide Aided by Diphenylphosphinyloxyl Diphenyl Ketone (DDK) Derivatives.
Chang, N; Chao, J; Li, H; Li, J; Qin, C; Tian, G; Zhang, Z, 2020)		2.28
"Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. "( Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.
Chey, WD; Franklin, H; Menees, SB, 2020)		2.36
"Plecanatide is a promising option for patients whose CIC symptoms are not adequately controlled using their current treatment approach."( Current treatment paradigm and landscape for the management of chronic idiopathic constipation in adults: Focus on plecanatide.
Martinez de Andino, N, 2018)		1.41
"Plecanatide is a safe and effective medication for the management of adults with CIC."( Benefit-Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation.
Miner, PB, 2019)		1.53

Effects

ExcerptReferenceRelevance
"Plecanatide has been approved by the FDA for use in chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation."( Benefit-Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation.
Miner, PB, 2019)		1.53

Treatment

ExcerptReferenceRelevance
"Plecanatide treatment is safe and efficacious for patients with CIC when administered with concomitant acid suppression medication."( The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.
Franklin, H; Moshiree, B; Rezaie, A; Schoenfeld, P, 2022)		2.4

Toxicity

Plecanatide treatment is safe and efficacious for patients with CIC when administered with concomitant acid suppression medication. Ple canatide was safe and well-tolerated at all dose levels.

ExcerptReferenceRelevance
" All adverse events were documented."( Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.
Barrow, L; Comer, GM; Comiskey, S; Feng, R; Foss, JA; Jacob, GS; Shailubhai, K, 2013)		1.83
"Plecanatide was safe and well-tolerated at all dose levels."( Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.
Barrow, L; Comer, GM; Comiskey, S; Feng, R; Foss, JA; Jacob, GS; Shailubhai, K, 2013)		3.28
"Plecanatide, an oral GC-C agonist, acting locally within the GI tract without measurable systemic exposure, was safe and well-tolerated in single doses up to 48."( Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.
Barrow, L; Comer, GM; Comiskey, S; Feng, R; Foss, JA; Jacob, GS; Shailubhai, K, 2013)		3.28
" Safety and tolerability were assessed by the incidence, nature, and severity of spontaneously reported treatment-emergent adverse events (TEAEs)."( Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.
Barish, CF; Griffin, P, 2018)		0.78
"Long-term treatment of adults with CIC demonstrated that plecanatide was safe and well tolerated, with low TEAE and discontinuation rates."( Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.
Barish, CF; Griffin, P, 2018)		1.02
" Safety was assessed by adverse events (AEs)."( Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials.
Brenner, DM; Crozier, RA; Dorn, SD; Eng, P; Fogel, R; Griffin, PH; Kirshoff, R; Krause, R; Magnus, L; Nguyen, A, 2018)		0.75
" Diarrhea was the most frequently reported treatment-emergent adverse event."( Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.
Barish, C; Dorn, S; Fogel, RP; Patel, R; Rosenberg, J, 2021)		2.06
"Plecanatide treatment is safe and efficacious for patients with CIC when administered with concomitant acid suppression medication."( The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.
Franklin, H; Moshiree, B; Rezaie, A; Schoenfeld, P, 2022)		2.4
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (7)

Assay IDTitleYearJournalArticle
AID1345486Human Guanylyl cyclase-C (Receptor Guanylyl Cyclase (RGC) family)2013Digestive diseases and sciences, Sep, Volume: 58, Issue:9
Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.
AID1388645Toxicity in in patient with chronic idiopathic constipation assessed as induction of diarrhea at 3 mg for 12 weeks (Rvb = 1.3%)2018Bioorganic & medicinal chemistry, 06-01, Volume: 26, Issue:10
Peptide therapeutics for the treatment of gastrointestinal disorders.
AID1388648Increase in complete spontaneous bowel movements in patient with chronic idiopathic constipation at 6 mg for 12 weeks (Rvb = 10.2%)2018Bioorganic & medicinal chemistry, 06-01, Volume: 26, Issue:10
Peptide therapeutics for the treatment of gastrointestinal disorders.
AID1388646Toxicity in in patient with chronic idiopathic constipation assessed as induction of diarrhea at 6 mg for 12 weeks (Rvb = 1.3%)2018Bioorganic & medicinal chemistry, 06-01, Volume: 26, Issue:10
Peptide therapeutics for the treatment of gastrointestinal disorders.
AID1882821Stability of the compound in simulated gastric fluid at pH 1.2 assessed as half life measured up to 24 hrs by RP-HPLC-UV analysis2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
On the Utility of Chemical Strategies to Improve Peptide Gut Stability.
AID1882822Stability of the compound in simulated intestinal fluid at pH 6.8 assessed as half life measured up to 24 hrs by RP-HPLC-UV analysis2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
On the Utility of Chemical Strategies to Improve Peptide Gut Stability.
AID1388647Increase in complete spontaneous bowel movements in patient with chronic idiopathic constipation at 3 mg for 12 weeks (Rvb = 10.2%)2018Bioorganic & medicinal chemistry, 06-01, Volume: 26, Issue:10
Peptide therapeutics for the treatment of gastrointestinal disorders.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (38)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's30 (78.95)24.3611
2020's8 (21.05)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 81.70

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index81.70 (24.57)
Research Supply Index3.89 (2.92)
Research Growth Index4.56 (4.65)
Search Engine Demand Index140.80 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (81.70)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials9 (23.08%)5.53%
Reviews11 (28.21%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other19 (48.72%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (14)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC) [NCT03120520]Phase 2124 participants (Actual)Interventional2017-01-31Completed
An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [NCT02706483]Phase 32,272 participants (Actual)Interventional2016-01-31Completed
A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE [NCT03551873]7 participants (Actual)Observational2018-06-21Completed
Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers [NCT05107219]Phase 143 participants (Anticipated)Interventional2022-10-25Recruiting
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 Weeks [NCT05151328]Phase 3640 participants (Anticipated)Interventional2022-03-18Recruiting
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation [NCT01053962]Phase 284 participants (Actual)Interventional2010-03-31Completed
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [NCT02387359]Phase 31,054 participants (Actual)Interventional2014-12-31Completed
A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation [NCT02122471]Phase 31,410 participants (Actual)Interventional2014-04-30Completed
An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC) [NCT01919697]Phase 32,370 participants (Actual)Interventional2013-08-31Completed
A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [NCT01722318]Phase 2428 participants (Actual)Interventional2012-11-30Completed
Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [NCT02493452]Phase 31,135 participants (Actual)Interventional2015-06-30Completed
Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation [NCT01429987]Phase 2/Phase 3951 participants (Actual)Interventional2011-10-31Completed
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study) [NCT01982240]Phase 31,394 participants (Actual)Interventional2013-11-30Completed
A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C) [NCT03596905]Phase 2210 participants (Anticipated)Interventional2018-06-30Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01053962 (5) [back to overview]Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
NCT01053962 (5) [back to overview]Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
NCT01053962 (5) [back to overview]Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
NCT01053962 (5) [back to overview]Changes From Baseline Overall in Ease of Passage (Straining)
NCT01053962 (5) [back to overview]Number of Participants With Adverse Events
NCT01429987 (5) [back to overview]Overall Responder 9/12 Weeks
NCT01429987 (5) [back to overview]Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
NCT01429987 (5) [back to overview]Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
NCT01429987 (5) [back to overview]Change From Baseline in 12-week CSBM Weekly Frequency Rate
NCT01429987 (5) [back to overview]Change From Baseline in 12-week SBM Weekly Frequency Rate
NCT01722318 (4) [back to overview]Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
NCT01722318 (4) [back to overview]Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)
NCT01722318 (4) [back to overview]Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
NCT01722318 (4) [back to overview]Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
NCT01919697 (12) [back to overview]Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364
NCT01919697 (12) [back to overview]Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment
NCT01919697 (12) [back to overview]Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364
NCT01919697 (12) [back to overview]Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364
NCT01919697 (12) [back to overview]Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)
NCT01919697 (12) [back to overview]Summary of ECG Results Shift From Baseline at > Day 364
NCT01919697 (12) [back to overview]Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)
NCT01919697 (12) [back to overview]Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)
NCT01919697 (12) [back to overview]Summary of Vital Signs at >Day 364 - Body Temperature (°C)
NCT01919697 (12) [back to overview]Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline
NCT01919697 (12) [back to overview]Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
NCT01919697 (12) [back to overview]Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide
NCT01982240 (5) [back to overview]Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
NCT01982240 (5) [back to overview]Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
NCT01982240 (5) [back to overview]Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
NCT01982240 (5) [back to overview]Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach
NCT01982240 (5) [back to overview]Number of Durable Overall CSBM Responders , Mean Replacement Approach
NCT02122471 (5) [back to overview]Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach
NCT02122471 (5) [back to overview]Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach
NCT02122471 (5) [back to overview]Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach
NCT02122471 (5) [back to overview]Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach
NCT02122471 (5) [back to overview]Number of Durable Overall CSBM Responders, Mean Replacement Approach
NCT02387359 (9) [back to overview]Change From Baseline in Straining
NCT02387359 (9) [back to overview]Change From Baseline in Stool Consistency
NCT02387359 (9) [back to overview]Change From Baseline in CSBM Frequency Rate
NCT02387359 (9) [back to overview]Change From Baseline in Abdominal Pain
NCT02387359 (9) [back to overview]Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
NCT02387359 (9) [back to overview]Number of Patients With a SBM Within 24 Hours After the First Dose
NCT02387359 (9) [back to overview]Number of Overall Responders - ITT Population
NCT02387359 (9) [back to overview]Number of Sustained Efficacy Responders
NCT02387359 (9) [back to overview]Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
NCT02493452 (9) [back to overview]Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
NCT02493452 (9) [back to overview]Number of Overall Responders - ITT Population
NCT02493452 (9) [back to overview]Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
NCT02493452 (9) [back to overview]Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
NCT02493452 (9) [back to overview]Change From Baseline in Abdominal Pain
NCT02493452 (9) [back to overview]Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
NCT02493452 (9) [back to overview]Change From Baseline in Stool Consistency
NCT02493452 (9) [back to overview]Change From Baseline in Straining
NCT02493452 (9) [back to overview]Number of Sustained Efficacy Responders
NCT02706483 (1) [back to overview]Number of Participants With Treatment Related Adverse Events.
NCT03120520 (4) [back to overview]Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)
NCT03120520 (4) [back to overview]Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score
NCT03120520 (4) [back to overview]Proportion of Overall Responders
NCT03120520 (4) [back to overview]Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)

Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)

Using a Daily Diary, patients recorded Stool Consistency using the 7-point Bristol Stool Form Scale (BSFS) (1 = separate hard lumps, like nuts; 2 sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces, entirely liquid). Changes in mean BSFS were assessed from the average 14-day pretreatment baseline to the average during the 2-week treatment period. (NCT01053962)
Timeframe: Study day 1 through 14

Interventionunits on a scale (Mean)
SP-304 0.3 mg1.1
SP-304 1.0 mg1.8
SP-304 3.0 mg1.6
SP-304 9.0 mg1.8
Placebo0.9

[back to top]

Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)

Using a Daily Diary, patients recorded the number of spontaneous bowel movements having the sensation of complete evacuation (Complete Spontaneous Bowel Movement - CSBM). The total number of spontaneous bowel movements associated with a feeling of complete evacuation were summed and divided by 2 (the number of weeks in treatment). Change was calculated as the difference between the number of the CSBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline. (NCT01053962)
Timeframe: Study days 1 through 14

InterventionCSBMs per week (Mean)
SP-304 0.3 mg1.7
SP-304 1.0 mg3.3
SP-304 3.0 mg1.8
SP-304 9.0 mg2.7
Placebo2.0

[back to top]

Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)

Using a Daily Diary, patients recorded the number of spontaneous bowel movements (SBM). The overall weekly frequency was calculated as the total number of SBMs divided by 2 (the number weeks of treatment). Change was calculated as the difference between the number of the SBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline. (NCT01053962)
Timeframe: Study Days 1 through 14

InterventionSBMs per week (Mean)
SP-304 0.3 mg2.4
SP-304 1.0 mg4.1
SP-304 3.0 mg2.4
SP-304 9.0 mg4.2
Placebo2.4

[back to top]

Changes From Baseline Overall in Ease of Passage (Straining)

Using a Daily Diary, patients recorded Ease of Passage (Straining) using the 7-point Ease-of-Passage Scale (1 = manual disimpaction/enema needed, 2 = severe straining, 3 = moderate straining, 4 = mild straining, 5 = no straining, 6 = urgency, 7 = incontinent). Changes in overall ease of passage (Straining) were assessed from the average 14-day pretreatment baseline to average during the 2-week treatment period (NCT01053962)
Timeframe: Study Days 1 through 14

Interventionunits on a scale (Mean)
SP-304 0.3 mg0.9
SP-304 1.0 mg1.6
SP-304 3.0 mg1.3
SP-304 9.0 mg1.2
Placebo0.5

[back to top]

Number of Participants With Adverse Events

Incidences of adverse events from Baseline through the end of the Follow-up period. (NCT01053962)
Timeframe: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)

InterventionParticipants (Count of Participants)
SP-304 0.3 mg3
SP-304 1.0 mg6
SP-304 3.0 mg2
SP-304 9.0 mg6
Placebo4

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Overall Responder 9/12 Weeks

A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. (NCT01429987)
Timeframe: 12-Week Treatment Period

Intervention% of Overall Responder 9/12 weeks (Number)
Plecanatide 0.3 mg18.6
Plecanatide 1.0 mg16.8
Plecanatide 3.0 mg19.0
Placebo10.7

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Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period

"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)" (NCT01429987)
Timeframe: 12-Week Treatment Period

Interventionscores on a scale (Least Squares Mean)
Plecanatide 0.3 mg1.28
Plecanatide 1.0 mg1.70
Plecanatide 3.0 mg1.97
Placebo0.87

[back to top]

Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score

The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst (NCT01429987)
Timeframe: 12-Week Treatment Period

Interventionscores on a scale (Least Squares Mean)
Plecanatide 0.3 mg-1.25
Plecanatide 1.0 mg-1.46
Plecanatide 3.0 mg-1.73
Placebo-1.04

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Change From Baseline in 12-week CSBM Weekly Frequency Rate

The number of Complete Spontaneous Bowel Movements (CSBMs) per week (NCT01429987)
Timeframe: 12-Week Treatment Period

InterventionCSBMs per week (Least Squares Mean)
Plecanatide 0.3 mg1.60
Plecanatide 1.0 mg1.81
Plecanatide 3.0 mg2.18
Placebo1.09

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Change From Baseline in 12-week SBM Weekly Frequency Rate

The number of Spontaneous Bowl Movements experienced per week. (NCT01429987)
Timeframe: 12-Week Treatment Period

InterventionSBMs per week (Least Squares Mean)
Plecanatide 0.3 mg2.20
Plecanatide 1.0 mg2.38
Plecanatide 3.0 mg3.00
Placebo1.35

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Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)

The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. (NCT01722318)
Timeframe: 12 weeks Treatment Period

InterventionCSBMs per week (Least Squares Mean)
Plecanatide 0.3mg1.28
Plecanatide 1.0mg2.12
Plecanatide 3.0mg2.74
Plecanatide 9.0mg2.44
Placebo1.27

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Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)

The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe (NCT01722318)
Timeframe: 12-Week Treatment Period

Interventionscore on a scale (Least Squares Mean)
Plecanatide 0.3mg-1.7
Plecanatide 1.0mg-1.5
Plecanatide 3.0mg-2.2
Plecanatide 9.0mg-2.1
Placebo-1.3

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Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)

"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)" (NCT01722318)
Timeframe: 12-Week Treatment Period

Interventionscores on a scale (Least Squares Mean)
Plecanatide 0.3mg1.63
Plecanatide 1.0mg1.81
Plecanatide 3.0mg2.49
Plecanatide 9.0mg2.24
Placebo1.01

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Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)

Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst. (NCT01722318)
Timeframe: 12-Week Treatment Period

Interventionscores on a scale (Least Squares Mean)
Plecanatide 0.3mg-1.5
Plecanatide 1.0mg-1.5
Plecanatide 3.0mg-2.0
Plecanatide 9.0mg-1.8
Placebo-1.4

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Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionscore on a scale (Mean)
Plecanatide 3 mg1.8
Plecantide 6 mg1.7

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Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionscore on a scale (Mean)
Plecanatide 3 mg4.1
Plecantide 6 mg4.1

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Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied. (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionscore on a scale (Mean)
Plecanatide 3 mg4.1
Plecantide 6 mg4.2

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Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. (NCT01919697)
Timeframe: Form first dose up to 72 weeks

Interventionscore on a scale (Mean)
Plecanatide 3 mg1.8
Plecantide 6 mg1.7

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Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). (NCT01919697)
Timeframe: From first dose up to 72 weeks

,
InterventionmmHg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
Plecanatide 3 mg12175.7
Plecantide 6 mg122.976.5

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Summary of ECG Results Shift From Baseline at > Day 364

Baseline was defined as the last non-missing value collected prior to first dose of study drug) (NCT01919697)
Timeframe: From first dose up to 72 weeks

,
Interventionparticipants (Number)
Change from Normal to AbnormalChange from Adnormal to Normal
Plecanatide 3 mg2715
Plecantide 6 mg4244

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Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionbreaths per minute (Mean)
Plecanatide 3 mg15.7
Plecantide 6 mg16.0

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Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionbeats per minute (Mean)
Plecanatide 3 mg71.2
Plecantide 6 mg71.9

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Summary of Vital Signs at >Day 364 - Body Temperature (°C)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). (NCT01919697)
Timeframe: From first dose up to 72 weeks

Intervention°C (Mean)
Plecanatide 3 mg36.62
Plecantide 6 mg36.59

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Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE. (NCT01919697)
Timeframe: From first dose up to 72 weeks

Interventionparticipants (Number)
Plecanatide 3 mg192
Plecantide 6 mg1498

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Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE. (NCT01919697)
Timeframe: From first dose up to 72 weeks

InterventionParticipants (Count of Participants)
Plecanatide 3 mg123
Plecantide 6 mg620

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Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug (NCT01919697)
Timeframe: From first dose up to 72 weeks

InterventionParticipants (Count of Participants)
Plecanatide 3 mg14
Plecantide 6 mg111

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Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach

A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. (NCT01982240)
Timeframe: 12-Week Treatment Period

,,
InterventionCSBMs per week (Mean)
BaselineWeek 12 change from baseline
Placebo0.391.45
Plecanatide 3.0 mg0.322.68
Plecanatide 6.0 mg0.322.39

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Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach

The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary. (NCT01982240)
Timeframe: 12-Week Treatment Period

,,
InterventionSBMs per week (Mean)
BaselineWeek 12 change from baseline
Placebo2.181.37
Plecanatide 3.0 mg1.973.30
Plecanatide 6.0 mg1.823.24

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Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach

"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)" (NCT01982240)
Timeframe: 12-Week Treatment Period

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
Placebo2.560.83
Plecanatide 3.0 mg2.521.56
Plecanatide 6.0 mg2.591.47

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Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach

Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. (NCT01982240)
Timeframe: 12-Week Treatment Period

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
Placebo2.30-0.95
Plecanatide 3.0 mg2.31-0.70
Plecanatide 6.0 mg2.28-1.00

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Number of Durable Overall CSBM Responders , Mean Replacement Approach

A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation. (NCT01982240)
Timeframe: 12-week Treatment Period

InterventionParticipants (Count of Participants)
Placebo46
Plecanatide 3.0 mg95
Plecanatide 6.0 mg86

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Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach

The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation. (NCT02122471)
Timeframe: Baseline and 12 weeks

,,
InterventionCSBMs per week (Least Squares Mean)
Baseline12 weeks
Placebo1.411.69
Plecanatide 3 mg2.342.66
Plecanatide 6 mg2.192.50

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Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach

The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was analyzed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period. (NCT02122471)
Timeframe: Baseline and 12 weeks

,,
InterventionSBMs per week (Mean)
Baseline12 weeks
Placebo1.551.81
Plecanatide 3 mg1.793.25
Plecanatide 6 mg1.633.10

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Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach

The change from baseline in the straining score over the 12-week Treatment Period was analyzed. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. (NCT02122471)
Timeframe: Baseline and 12 weeks

,,
Interventionscore on a scale (Mean)
Baseline12 weeks
Placebo2.42-0.79
Plecanatide 3 mg2.46-1.09
Plecanatide 6 mg2.47-1.04

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Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach

"The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary.~The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)" (NCT02122471)
Timeframe: Baseline and 12 weeks

,,
Interventionscore on a scale (Mean)
Baseline12 weeks
Placebo2.351.02
Plecanatide 3 mg2.161.71
Plecanatide 6 mg2.271.59

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Number of Durable Overall CSBM Responders, Mean Replacement Approach

The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation. (NCT02122471)
Timeframe: 12-Week Treatment Period

InterventionParticipants (Count of Participants)
Placebo57
Plecanatide 3 mg88
Plecanatide 6 mg88

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Change From Baseline in Straining

Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining). (NCT02387359)
Timeframe: Baseline and 12-week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide6.47-2.69
6.0 mg Plecanatide6.50-2.88
Matching Placebo6.39-1.87

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Change From Baseline in Stool Consistency

"Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:~Separate hard lumps, like nuts (hard to pass)~Sausage-shaped but lumpy~Like a sausage but with cracks on its surface~Like a sausage or snake, smooth and soft~Soft blobs with clear-cut edges (passed easily)~Fluffy pieces with ragged edges, a mushy stool~Watery, no solid pieces, entirely liquid" (NCT02387359)
Timeframe: Baseline and 12-Week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide2.021.59
6.0 mg Plecanatide1.981.86
Matching Placebo2.061.06

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Change From Baseline in CSBM Frequency Rate

Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02387359)
Timeframe: Baseline and 12-Week

,,
InterventionCSBMs per week (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide0.221.46
6.0 mg Plecanatide0.281.41
Matching Placebo0.230.86

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Change From Baseline in Abdominal Pain

Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02387359)
Timeframe: Baseline and 12-Week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide5.94-2.11
6.0 mg Plecanatide5.95-2.46
Matching Placebo6.10-1.79

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Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks

A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02387359)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Matching Placebo124
3.0 mg Plecanatide169
6.0 mg Plecanatide157

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Number of Patients With a SBM Within 24 Hours After the First Dose

Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug (NCT02387359)
Timeframe: Up to 24 hours after first dose of study drug

InterventionParticipants (Count of Participants)
Matching Placebo118
3.0 mg Plecanatide168
6.0 mg Plecanatide175

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Number of Overall Responders - ITT Population

An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks. (NCT02387359)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Matching Placebo63
3.0 mg Plecanatide106
6.0 mg Plecanatide103

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Number of Sustained Efficacy Responders

A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period. (NCT02387359)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Matching Placebo61
3.0 mg Plecanatide99
6.0 mg Plecanatide96

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Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks

An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02387359)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Matching Placebo112
3.0 mg Plecanatide145
6.0 mg Plecanatide156

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Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks

An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02493452)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Matching Placebo88
3.0 mg Plecanatide123
6.0 mg Plecanatide129

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Number of Overall Responders - ITT Population

An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks. (NCT02493452)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Matching Placebo54
3.0 mg Plecanatide81
6.0 mg Plecanatide91

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Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication

A responder was any patient with a SBM within 24 hours after the first dose of study drug. (NCT02493452)
Timeframe: Up to 24 hours after the first dose of study drug

InterventionParticipants (Count of Participants)
Matching Placebo119
3.0 mg Plecanatide157
6.0 mg Plecanatide167

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Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks

A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02493452)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Matching Placebo106
3.0 mg Plecanatide129
6.0 mg Plecanatide148

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Change From Baseline in Abdominal Pain

Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week. (NCT02493452)
Timeframe: Baseline and 12-Week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide6.56-2.00
6.0 mg Plecanatide6.48-1.87
Matching Placebo6.40-1.42

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Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement

Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. (NCT02493452)
Timeframe: Baseline and 12-Week

,,
InterventionCSBMs per week (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide0.261.23
6.0 mg Plecanatide0.271.63
Matching Placebo0.240.80

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Change From Baseline in Stool Consistency

"Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:~Separate hard lumps, like nuts (hard to pass)~Sausage-shaped but lumpy~Like a sausage but with cracks on its surface~Like a sausage or snake, smooth and soft~Soft blobs with clear-cut edges (passed easily)~Fluffy pieces with ragged edges, a mushy stool~Watery, no solid pieces, entirely liquid" (NCT02493452)
Timeframe: Baseline and 12-Week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide1.911.55
6.0 mg Plecanatide1.861.45
Matching Placebo1.991.04

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Change From Baseline in Straining

Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining). (NCT02493452)
Timeframe: Baseline and 12-Week

,,
Interventionscore on a scale (Mean)
BaselineWeek 12 change from baseline
3.0 mg Plecanatide6.84-2.35
6.0 mg Plecanatide6.87-2.35
Matching Placebo6.75-1.66

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Number of Sustained Efficacy Responders

A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period. (NCT02493452)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Matching Placebo53
3.0 mg Plecanatide78
6.0 mg Plecanatide90

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Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)

The weekly Spontaneous Bowel Movement (SBM) totals were derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. SBM is defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours (NCT03120520)
Timeframe: 8 weeks

InterventionWeekly SBMs (Least Squares Mean)
Matching Placebo1.44
Plecanatide 0.5 mg1.97
Plecanatide 1.0 mg2.06
Plecanatide 1.5 mg2.05

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Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score

Stool consistency was assessed via the 7-point (1-7) Bristol Stool Form Scale (BSFS) and recorded in the bowel movement (BM) and Symptom Diaries. Lower numbers represent more formed stools; higher numbers represent less formed stools. The weekly mean BSFS score per patient = (total of all BSFS scores reported for a corresponding Spontaneous Bowel Movement (SBM) per time period)/n, where n = number of SBMs scored during the time period. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS types were 1) separate hard lumps, like nuts (hard to pass); 2) sausage-shaped but lumpy; 3) like a sausage but with cracks on its surface; 4) like a sausage or snake, smooth and soft; 5) soft blobs with clear-cut edges (passed easily); 6) fluffy pieces with ragged edges, a mushy stool; 7) watery, no solid pieces, entirely liquid. (NCT03120520)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Matching Placebo0.98
Plecanatide 0.5 mg1.09
Plecanatide 1.0 mg1.22
Plecanatide 1.5 mg1.06

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Proportion of Overall Responders

An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had >3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders. (NCT03120520)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Matching Placebo7
Plecanatide 0.5 mg10
Plecanatide 1.0 mg12
Plecanatide 1.5 mg7

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Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)

The weekly Complete Spontaneous Bowel Movement (CSBM) totals are derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline is the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. CSBM was defined as a spontaneous bowel movement with the sense of complete evacuation. (NCT03120520)
Timeframe: 8 weeks

InterventionWeekly CSBMs (Least Squares Mean)
Matching Placebo1.30
Plecanatide 0.5 mg1.71
Plecanatide 1.0 mg1.83
Plecanatide 1.5 mg2.11

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
carbamates
[no description available]		2.1710amino-acid anion
chlorine
chloride : A halide anion formed when chlorine picks up an electron to form an an anion.		2.1110halide anion;
monoatomic chlorine		cofactor;
Escherichia coli metabolite;
human metabolite
alosetron
alosetron : A pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position.		2.1310imidazoles;
pyridoindole		antiemetic;
gastrointestinal drug;
serotonergic antagonist
antipyrine
Antipyrine: An analgesic and antipyretic that has been given by mouth and as ear drops. Antipyrine is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. (From Martindale, The Extra Pharmacopoeia, 30th ed, p29). antipyrine : A pyrazolone derivative that is 1,2-dihydropyrazol-3-one substituted with methyl groups at N-1 and C-5 and with a phenyl group at N-2.		2.1710pyrazoloneantipyretic;
cyclooxygenase 3 inhibitor;
environmental contaminant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
loperamide
Loperamide: One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.. loperamide : A synthetic piperidine derivative, effective against diarrhoea resulting from gastroenteritis or inflammatory bowel disease.		2.1310monocarboxylic acid amide;
monochlorobenzenes;
piperidines;
tertiary alcohol		anticoronaviral agent;
antidiarrhoeal drug;
mu-opioid receptor agonist
edaravone
[no description available]		2.1710pyrazoloneantioxidant;
radical scavenger
alanine
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.		2.1710alanine zwitterion;
alanine;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid		EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor;
fundamental metabolite
tetrabenazine
9,10-dimethoxy-3-isobutyl-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one : A benzoquinolizine that is 1,2,3,4,4a,9,10,10a-octahydrophenanthrene in which the carbon at position 10a is replaced by a nitrogen and which is substituted by an isobutyl group at position 2, an oxo group at position 3, and methoxy groups at positions 6 and 7.		2.1710benzoquinolizine;
cyclic ketone;
tertiary amino compound
leucine
Leucine: An essential branched-chain amino acid important for hemoglobin formation.. leucine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isobutyl group.		2.1710amino acid zwitterion;
L-alpha-amino acid;
leucine;
proteinogenic amino acid;
pyruvate family amino acid		algal metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
plant metabolite;
Saccharomyces cerevisiae metabolite
phenylalanine
Phenylalanine: An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.. L-phenylalanine : The L-enantiomer of phenylalanine.. phenylalanine : An aromatic amino acid that is alanine in which one of the methyl hydrogens is substituted by a phenyl group.		2.1310amino acid zwitterion;
erythrose 4-phosphate/phosphoenolpyruvate family amino acid;
L-alpha-amino acid;
phenylalanine;
proteinogenic amino acid		algal metabolite;
EC 3.1.3.1 (alkaline phosphatase) inhibitor;
Escherichia coli metabolite;
human xenobiotic metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
plant metabolite;
Saccharomyces cerevisiae metabolite
valine
Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine.		2.1710L-alpha-amino acid zwitterion;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid;
valine		algal metabolite;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
quinoxalines
quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4.		2.1710mancude organic heterobicyclic parent;
naphthyridine;
ortho-fused heteroarene
trinitrobenzenesulfonic acid
Trinitrobenzenesulfonic Acid: A reagent that is used to neutralize peptide terminal amino groups.. 2,4,6-trinitrobenzenesulfonic acid : The arenesulfonic acid that is benzenesulfonic acid with three nitro substituents in the 2-, 4- and 6-positions.		2.1710arenesulfonic acid;
C-nitro compound		epitope;
explosive;
reagent
fluorescein-5-isothiocyanate
Fluorescein-5-isothiocyanate: Fluorescent probe capable of being conjugated to tissue and proteins. It is used as a label in fluorescent antibody staining procedures as well as protein- and amino acid-binding techniques.. fluorescein 5-isothiocyanate : The 5-isomer of fluorescein isothiocyanate. Acts as a fluorescent probe capable of being conjugated to tissue and proteins; used as a label in fluorescent antibody staining procedures as well as protein- and amino acid-binding techniques.		2.1710fluorescein isothiocyanate
colestipol
Colestipol: Highly crosslinked and insoluble basic anion exchange resin used as anticholesteremic. It may also may reduce triglyceride levels.. colestipol : A high molecular weight copolymer of diethylenetriamine and epichlorohydrin (hydrochloride), with approximately 1 out of 5 amine nitrogens protonated. Due to the highly cross-linked and insoluble nature of the material, no structural formula has been assigned and no specific molecular weight information is available. A basic anion exchange resin, it is used as its hydrochloride for binding bile acids in the intestine, inhibiting their reabsorption.		2.1310
ramosetron
[no description available]		2.1310indoles
safinamide
safinamide: short-acting inhibitor of MOA-B; FCE 26743 is (S)-isomer, FCE 28073 is (R)-isomer; structure in first source		2.1710amino acid amide
proline
Proline: A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.. proline : An alpha-amino acid that is pyrrolidine bearing a carboxy substituent at position 2.		2.1710amino acid zwitterion;
glutamine family amino acid;
L-alpha-amino acid;
proline;
proteinogenic amino acid		algal metabolite;
compatible osmolytes;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
lubiprostone
[no description available]		4.6940
benzofurans
Benzofurans: Compounds that contain a BENZENE ring fused to a furan ring.		3.6120
oxytocin
Oxytocin: A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.. oxytocin : A cyclic nonapeptide hormone with amino acid sequence CYIQNCPLG that also acts as a neurotransmitter in the brain; the principal uterine-contracting and milk-ejecting hormone of the posterior pituitary. Together with the neuropeptide vasopressin, it is believed to influence social cognition and behaviour.		2.4110heterodetic cyclic peptide;
peptide hormone		oxytocic;
vasodilator agent
octreotide
[no description available]		2.4110
arginine vasopressin
Arginine Vasopressin: The predominant form of mammalian antidiuretic hormone. It is a nonapeptide containing an ARGININE at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. Arg-vasopressin is used to treat DIABETES INSIPIDUS or to improve vasomotor tone and BLOOD PRESSURE.. argipressin : The predominant form of mammalian vasopressin (antidiuretic hormone). It is a nonapeptide containing an arginine at residue 8 and two disulfide-linked cysteines at residues of 1 and 6.		2.4110vasopressincardiovascular drug;
hematologic agent;
mitogen
prucalopride
prucalopride: a 5-HT4 agonist enterokinetic compound		3.6120benzamides
deamino arginine vasopressin
Deamino Arginine Vasopressin: A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.		2.4110heterodetic cyclic peptidediagnostic agent;
renal agent;
vasopressin receptor agonist
naltrexone
Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence.		2.1710cyclopropanes;
morphinane-like compound;
organic heteropentacyclic compound		antidote to opioid poisoning;
central nervous system depressant;
environmental contaminant;
mu-opioid receptor antagonist;
xenobiotic
uroguanylin
uroguanylin: amino acid sequence given in first source; stimulates intestinal guanylate cyclase; GenBank Z83746 (pig)		4.3550
guanylin
guanylin: from rat jejunum; contains 15 amino acids; activator of intestinal guanylate cyclase; stimulates this enzyme through the same receptor binding region as the heat-stable enterotoxins; amino acid sequence given in first source; GenBank Z73607 (pig)		2.1110
elobixibat
elobixibat: inhibits ileal bile acid transporter		3.1910
betrixaban
betrixaban: a highly potent, selective, and orally efficacious factor Xa inhibitor; structure in first source. betrixaban : A secondary carboxamide obtained by formal condensation of the carboxy group of 4-(N,N-dimethylcarbamimidoyl)benzoic acid with the amino group of 2-amino-N-(5-chloropyridin-2-yl)-5-methoxybenzamide. A synthetic anticoagulant compound that targets activated factor Xa in the coagulation cascade.		2.5820benzamides;
guanidines;
monochloropyridine;
monomethoxybenzene;
secondary carboxamide		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor
eluxadoline
[no description available]		2.1310amino acid amide;
benzamides;
imidazoles;
L-phenylalanine derivative;
methoxybenzoic acid		delta-opioid receptor antagonist;
gastrointestinal drug;
kappa-opioid receptor agonist;
mu-opioid receptor agonist
ulimorelin
ulimorelin: ghrelin agonist; an 18-membered macrocycle containing 3 amide bonds and a secondary amine as well as 4 stereogenic centers; belongs to macrocyclic peptidomimetics		3.2710oligopeptide
rifamycins
[no description available]		2.1310
somatostatin
[no description available]		2.4110heterodetic cyclic peptide;
peptide hormone
alx-0600
ALX-0600: glucagon-like peptide 2 (GLP-2) analog. teduglutide : A 33-membered polypeptide consisting of His, Gly, Asp, Gly, Ser, Phe, Ser, Asp, Glu, Met, Asn, Thr, Ile, Leu, Asp, Asn, Leu, Ala, Ala, Arg, Asp, Phe, Ile, Asn, Trp, Leu, Ile, Gln, Thr, Lys, Ile, Thr and Asp residues joined in sequence. A glucagon-like peptide-2 receptor agonist used for the treatment of short-bowel syndrome.		3.2710polypeptideantioxidant;
glucagon-like peptide-2 receptor agonist;
metabolite;
protective agent
carbetocin
carbetocin : Oxytocin in which the hydrogen on the phenolic hydroxy group is substituted by methyl, the amino group on the cysteine residue is substituted by hydrogen, and the sulfur of the cysteine residue is replaced by a methylene group. A synthetic carba-analogue of oxytocin, it is used to control bleeding after giving birth. Like oxytocin, it causes contraction of the uterus.		2.4110heterodetic cyclic peptideoxytocic
valbenazine
valbenazine: inhibits vesicular monoamine transporter 2 (VMAT2); used to treat tardive dyskinesia; structure in first source		2.1710
sofosbuvir
Sofosbuvir: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.. sofosbuvir : A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection.		2.1710isopropyl ester;
L-alanyl ester;
nucleotide conjugate;
organofluorine compound;
phosphoramidate ester		antiviral drug;
hepatitis C protease inhibitor;
prodrug
gs-5816
velpatasvir: an NS5A inhibitor used for treating hepatitis C infections. velpatasvir : A complex organic heteropentacyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with sofosbuvir (under the brand name Epclusa) for treatment of patients with chronic hepatitis C of all six major genotypes.		2.1710carbamate ester;
ether;
imidazoles;
L-valine derivative;
N-acylpyrrolidine;
organic heteropentacyclic compound;
ring assembly		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor
tenapanor
[no description available]		4.2220
tegaserod
tegaserod: a nonbenzamide 5-hydroxytryptamine(4) agonist; used in treatment of irritable bowel syndrome; marketing suspended 2007 in US due to higher incidence of MI, stroke, and unstable angina; structure given in first source		2.1310carboxamidine;
guanidines;
hydrazines;
indoles		gastrointestinal drug;
serotonergic agonist
cyclic guanosine monophosphate-adenosine monophosphate
2'-3'-cGAMP : A cyclic purine dinucleotide that consists of AMP and GMP units cyclised via 3',5'- and 2',5'-linkages respectively.		2.2110adenyl ribonucleotide;
cyclic purine dinucleotide;
guanyl ribonucleotide
ConditionIndicatedRelationship StrengthStudiesTrials
Colonic Diseases, Functional
Chronic or recurrent colonic disorders without an identifiable structural or biochemical explanation. The widely recognized IRRITABLE BOWEL SYNDROME falls into this category.		03.8721
Cholera Infantum
[description not available]		03.4620
Chronic Illness
[description not available]		011.87166
Colitis, Mucous
[description not available]		015.083422
Colonic Inertia
Symptom characterized by the passage of stool once a week or less.		016.144926
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		011.87166
Constipation
Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections.		118.144926
Irritable Bowel Syndrome
A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.		117.083422
Diarrhea
An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.		09.2374
Colicky Pain
[description not available]		03.9721
Abdominal Pain
Sensation of discomfort, distress, or agony in the abdominal region.		08.9721
Tardive Dystonia
[description not available]		02.1710
Palmoplantaris Pustulosis
[description not available]		02.1710
Tardive Dyskinesia
Drug-related movement disorder characterized by uncontrollable movements in certain muscles. It is associated with a long-term exposure to certain neuroleptic medications (e.g., METOCLOPRAMIDE).		02.1710
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		02.1710
Visceral Pain
Pain originating from internal organs (VISCERA) associated with autonomic phenomena (PALLOR; SWEATING; NAUSEA; and VOMITING). It often becomes a REFERRED PAIN.		02.5520
Bowel Diseases, Inflammatory
[description not available]		02.1110
Inflammatory Bowel Diseases
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.		02.1110
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		02.1310