Page last updated: 2024-10-23

aspirin and Colonic Inertia

aspirin has been researched along with Colonic Inertia in 10 studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Colonic Inertia: Symptom characterized by the passage of stool once a week or less.

Research Excerpts

Excerpt	Relevance	Reference
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."	7.81	Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."	3.81	Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
"Chronic constipation, enteric-coated aspirin intake and splanchnic atherosclerosis are risk factors related to ulcer in IC patients."	3.80	[An analysis of clinical characteristics and risk factors for ulceration in ischemic colitis]. ( Li, X; Liao, L; Liu, W; Liu, Y; Shi, H; Wu, B, 2014)
"Chronic constipation is associated with use of acetaminophen, aspirin and non-steroidal anti-inflammatory drugs."	1.34	Risk factors for chronic constipation and a possible role of analgesics. ( Chang, JY; Locke, GR; Schleck, CD; Talley, NJ; Zinsmeister, AR, 2007)

Research

Studies (10)

Timeframe	Studies, this research(%)	All Research%
pre-1990	2 (20.00)	18.7374
1990's	2 (20.00)	18.2507
2000's	3 (30.00)	29.6817
2010's	3 (30.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Liu, W	1
Liao, L	1
Shi, H	1
Wu, B	1
Li, X	1
Liu, Y	1
O'Gorman, J	1
Russell, HK	1
Li, J	1
Phillips, G	1
Kurukulasuriya, NC	1
Viglietta, V	1
Melnyk, BM	1
Juarranz, M	1
Calle-Purón, ME	1
González-Navarro, A	1
Regidor-Poyatos, E	1
Soriano, T	1
Martínez-Hernandez, D	1
Rojas, VD	1
Guinee, VF	1
Chang, JY	1
Locke, GR	1
Schleck, CD	1
Zinsmeister, AR	2
Talley, NJ	3
Tuteja, AK	1
Joos, SK	1
Tolman, KG	1
Hickam, DH	1
Weaver, AL	1
Melton, LJ	1
Paton, A	1
Holmes, EL	1

Clinical Trials (4)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID[NCT01568112]	Phase 3	173 participants (Actual)	Interventional	2012-04-30	Completed
The Yield and Safety of Screening and Surveillance Colonoscopy in Elderly Patients (> 80 Years)[NCT00590434]		169 participants (Actual)	Observational	2006-08-31	Completed
Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial[NCT05842005]		15 participants (Anticipated)	Interventional	2023-01-01	Recruiting
A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)[NCT00256984]	Phase 4	75 participants (Actual)	Interventional	2005-10-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Duration of Flushing Events During the Overall Treatment Period, Based on MFSS

For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	minutes (Mean)
Placebo	98.4
BG00012	63.2
BG00012 + ASA	69.8
BG00012 Slow Titration	68.9

Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS

Intervention	minutes (Mean)
Placebo	117.6
BG00012	67.6
BG00012 + ASA	89.8
BG00012 Slow Titration	69.2

Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS

Intervention	minutes (Mean)
Placebo	113.2
BG00012	55.7
BG00012 + ASA	73.2
BG00012 Slow Titration	56.0

Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)

The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	percentage of participants (Number)
Placebo	73
BG00012	81
BG00012 + ASA	81
BG00012 Slow Titration	86

Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	percentage of participants (Number)
Placebo	59
BG00012	70
BG00012 + ASA	79
BG00012 Slow Titration	79

Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

Intervention	percentage of participants (Number)
Placebo	57
BG00012	65
BG00012 + ASA	67
BG00012 Slow Titration	71

Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

Intervention	percentage of participants (Number)
Placebo	66
BG00012	81
BG00012 + ASA	79
BG00012 Slow Titration	79

Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

Intervention	percentage of participants (Number)
Placebo	34
BG00012	59
BG00012 + ASA	50
BG00012 Slow Titration	58

Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

Intervention	percentage of participants (Number)
Placebo	41
BG00012	59
BG00012 + ASA	53
BG00012 Slow Titration	61

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)

Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 8

Intervention	percentage of participants (Number)
Placebo	43
BG00012	86
BG00012 + ASA	74
BG00012 Slow Titration	93

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 4

Intervention	percentage of participants (Number)
Placebo	41
BG00012	84
BG00012 + ASA	62
BG00012 Slow Titration	90

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score. (NCT01568112)
Timeframe: Week 5 to Week 8

Intervention	percentage of participants (Number)
Placebo	24
BG00012	86
BG00012 + ASA	67
BG00012 Slow Titration	85

Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry

Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	ALP: shift to high; n=44, 42, 43, 42	ALT: shift to high; n=44, 42, 43, 42	AST: shift to high; n=44, 43, 43, 41	GGT: shift to high; n=44, 41, 43, 42	LDH: shift to low; n=44, 43, 43, 42	LDH: shift to high; n=44, 43, 43, 42	Total bilirubin: shift to high; n=44, 42, 42, 40	BUN: shift to low; n=44, 43, 43, 42	BUN: shift to high; n=44, 43, 41, 42	Creatinine: shift to low; n=44, 43, 43, 42	Creatinine: shift to high; n=44, 43, 43, 42	Uric Acid: shift to low; n=44, 43, 43, 42	Uric Acid: shift to high; n=44, 43, 43, 42	Sodium: shift to low; n=44, 43, 43, 42	Sodium: shift to high; n=44, 43, 43, 42	Potassium: shift to low: n=44, 43, 43, 42	Potassium: shift to high: n=44, 42, 42, 41	Chloride: shift to low; n=44, 43, 43, 42	Chloride: shift to high; n=44, 43, 43, 42	Bicarbonate: shift to low; n=44, 43, 43, 42	Bicarbonate: shift to high; n=44, 43, 43, 42	Calcium: shift to low; n=44, 42, 43, 42	Calcium: shift to high; n=44, 43, 43, 42	Glucose: shift to low; n=43, 43, 41, 41	Glucose: shift to high; n=44, 43, 43, 42	Magnesium: shift to low; n=44, 43, 43, 42	Magnesium: shift to high; n=44, 43, 43, 42	Phosphorus: shift to low; n=44, 43, 43, 41	Phosphorus: shift to high; n=44, 43, 43, 42	Albumin: shift to low; n=44, 43, 43, 42	Albumin: shift to high; n=44, 43, 43, 42	Direct bilirubin: shift to high; n=44, 43, 43, 40	Total protein: shift to low; n=44, 41, 43, 41	Total protein: shift to high; n=44, 43, 43, 42
BG00012	0	2	3	0	0	0	1	0	0	1	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	0	1	0	0	0	0	0	0
BG00012 + ASA	0	5	4	2	0	1	0	0	1	0	0	0	0	0	1	0	1	0	0	1	0	1	0	1	0	0	0	0	0	0	0	0	1	0
BG00012 Slow Titration	0	2	1	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	0	1	0	0	0	0	0
Placebo	0	1	2	0	0	0	1	0	1	0	0	0	0	1	0	0	1	1	0	1	0	0	0	3	1	1	0	0	0	0	0	0	0	0

Clinical Laboratory Shifts From Baseline in Reported Values: Hematology

Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	White blood cells: shift to low; n=43, 43, 43, 41	White blood cells: shift to high; n=44, 43, 43, 42	Neutrophils abs: shift to low; n=42, 42, 42, 41	Neutrophils abs: shift to high; n=44, 43, 43, 42	Lymphocytes abs: shift to low; n=43, 43, 43, 41	Lymphocytes abs: shift to high; n=44, 43, 42, 42	Monocytes abs: shift to low; n=44, 43, 43, 42	Monocytes abs: shift to high; n=44, 43, 43, 42	Eosinophils abs: shift to low; n=44, 43, 43, 42	Eosinophils abs: shift to high; n=44, 43, 43, 42	Basophils abs: shift to high; n=44, 43, 43, 42	Red blood cells: shift to low; n=44, 43, 43, 40	Red blood cells: shift to high; n=44, 43, 43, 42	Hemoglobin: shift to low; n=43, 41, 43, 42	Hemoglobin: shift to high; n=44, 43, 43, 42	Hematocrit: shift to low; n=44, 43, 43, 42	Hematocrit: shift to high; n=43, 43, 43, 42	Platelets: shift to low; n=44, 43, 43, 42	Platelets: shift to high; n=44, 41, 43, 42
BG00012	2	0	6	0	5	0	0	0	0	5	1	2	0	3	0	2	0	0	0
BG00012 + ASA	0	1	2	0	2	0	0	0	0	6	1	0	0	1	0	0	0	0	1
BG00012 Slow Titration	0	0	2	1	3	0	0	0	0	6	0	0	0	0	0	0	1	0	1
Placebo	0	0	3	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0

Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis

Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	Specific gravity: shift to low; n=44, 43, 43, 42	Specific gravity: shift to high; n=44, 42, 43, 42	pH: shift to low; n=44, 43, 43, 42	pH: shift to high; n=44, 43, 43, 42	Blood: shift to positive; n=42, 39, 39, 42	Color: shift to positive; n=41, 43, 41, 39	Glucose: shift to positive; n=44, 43, 43, 41	Ketones: shift to positive; n=44, 43, 43, 42	Protein: shift to positive; n=44, 41, 43, 41	Microscopic RBC; n=44, 40, 40, 41	Microscopic WBC; n=43, 40, 41, 42
BG00012	0	0	0	0	6	1	2	7	1	4	9
BG00012 + ASA	0	2	0	0	1	4	1	9	1	1	3
BG00012 Slow Titration	0	0	0	0	2	5	0	6	1	2	3
Placebo	0	0	0	0	3	2	0	1	0	3	4

Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS

Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	hours (Mean)
	Nausea; n=12, 21, 21, 22	Diarrhea; n=20, 20 17, 15	Upper abdominal pain; n=17, 14, 19, 19	Lower abdominal pain; n=12, 19, 17, 16	Vomiting; n=3, 3, 3, 2	Indigestion; n=12, 13, 12, 12	Constipation; n=6, 8, 13, 11	Bloating; n=14, 14, 21, 12	Flatulence; n=23, 20, 22, 20
BG00012	7.05	2.92	6.67	13.93	10.08	16.49	28.20	16.91	9.06
BG00012 + ASA	10.01	14.66	15.88	10.84	1.88	3.80	14.26	9.68	68.93
BG00012 Slow Titration	2.98	4.97	3.83	7.75	0.75	4.91	20.90	77.24	63.84
Placebo	9.74	5.57	19.08	6.65	5.87	4.76	20.49	9.50	16.41

Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS

,,,

Intervention	hours (Mean)
	Nausea; n=10, 18, 18, 20	Diarrhea; n=13, 20, 14, 14	Upper abdominal pain; n=14, 14, 17, 15	Lower abdominal pain; n=9, 18, 14, 13	Vomiting; n=2, 2, 2, 2	Indigestion; n=11, 11, 9, 11	Constipation; n=4, 8, 11, 11	Bloating; n=9, 14, 19, 11	Flatulence; n=21, 17, 22, 19
BG00012	7.23	2.53	6.81	14.20	5.63	29.00	27.61	13.81	9.34
BG00012 + ASA	11.18	16.04	17.65	12.51	2.53	3.93	15.12	11.07	35.86
BG00012 Slow Titration	2.86	4.97	4.31	6.30	0.75	5.05	21.28	95.69	61.13
Placebo	10.47	5.20	21.37	5.40	4.31	5.08	17.05	6.70	12.83

Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS

,,,

Intervention	hours (Mean)
	Nausea; n=4, 9, 6, 9	Diarrhea; n=12, 13, 6, 8	Upper abdominal pain; n=6, 5, 5, 5	Lower abdominal pain; n=7, 5, 5, 9	Vomiting; n=1, 1, 1, 0	Indigestion; n=6, 7, 7, 5	Constipation; n=5, 2, 4, 4	Bloating; n=7, 8, 7, 8	Flatulence; n=9, 13, 7, 10
BG00012	4.34	6.62	1.12	3.98	19.00	2.57	15.47	18.52	7.21
BG00012 + ASA	2.66	7.05	1.86	2.84	0.58	5.02	21.30	4.16	105.86
BG00012 Slow Titration	2.34	2.14	1.73	22.54	NA	1.63	18.24	85.64	18.48
Placebo	3.96	4.50	5.29	6.63	9.00	2.43	23.35	12.49	44.67

Number of Participants With Abnormalities in Vital Signs

↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	Temperature >38°C + ↑ from BL of ≥1°C	Pulse >120 bpm or ↑ from BL of >20 bpm	Pulse <50 bpm or ↓ from BL of >20 bpm	SBP >180 mm Hg or ↑ from BL of >40 mm Hg	SBP <90 mm Hg or ↓ from BL of >30 mm Hg	DBP >105 mm Hg or ↑ from BL of >30 mm Hg	DBP <50 mm Hg or ↓ from BL of >20 mm Hg	Respiration rate >25 b/m or ↑ from BL of ≥50%	Respiration rate 10 b/m or ↓ from BL of ≥50%
BG00012	0	10	4	0	2	0	3	2	0
BG00012 + ASA	0	20	3	0	1	0	0	3	0
BG00012 Slow Titration	0	17	4	0	1	0	1	3	0
Placebo	0	8	11	1	1	0	1	1	0

Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results

Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.' (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	Shift to abnormal, not adverse event	Shift to abnormal, adverse event
BG00012	3	0
BG00012 + ASA	2	0
BG00012 Slow Titration	4	0
Placebo	2	0

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)

AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened. (NCT01568112)
Timeframe: Day 1 up to end of Safety Follow-up (9 weeks)

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Intervention	participants (Number)
	Any event	Moderate or severe event	Severe event	Related event	Serious event	Discontinuation of treatment due to an event	Withdrawal from study due to an event
BG00012	24	13	4	17	1	4	4
BG00012 + ASA	26	12	4	16	0	6	6
BG00012 Slow Titration	26	11	1	18	0	3	3
Placebo	24	10	0	8	0	2	2

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)

Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	91	86	93	88	86
BG00012 + ASA	81	77	84	67	72
BG00012 Slow Titration	98	90	98	86	98
Placebo	41	27	41	23	20

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS

Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 1 to Week 4

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	86	81	88	84	77
BG00012 + ASA	72	63	67	51	56
BG00012 Slow Titration	98	88	95	83	95
Placebo	41	25	41	23	16

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	86	78	86	81	78
BG00012 + ASA	72	64	75	64	58
BG00012 Slow Titration	85	79	82	70	61
Placebo	24	15	17	15	22

Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Day 1 to Week 4

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Intervention	units on a scale (Mean)
	Nausea	Diarrhea	Upper abdominal pain	Lower abdominal pain	Vomiting	Indigestion	Constipation	Bloating	Flatulence
BG00012	1.6	1.8	1.1	1.4	0.3	0.9	0.9	1.1	1.3
BG00012 + ASA	1.6	1.5	1.7	1.3	0.3	0.6	0.6	1.3	1.4
BG00012 Slow Titration	1.5	1.0	1.4	1.2	0.2	0.9	0.9	1.0	1.6
Placebo	0.7	1.0	0.8	0.5	0.2	0.7	0.4	0.5	1.3

Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

,,,

Intervention	units on a scale (Mean)
	Nausea	Diarrhea	Upper abdominal pain	Lower abdominal pain	Vomiting	Indigestion	Constipation	Bloating	Flatulence
BG00012	0.9	1.4	0.5	0.4	0.1	0.5	0.1	0.7	1.2
BG00012 + ASA	0.8	0.8	0.4	0.5	0.1	0.5	0.6	0.7	0.4
BG00012 Slow Titration	0.9	0.7	0.6	0.9	0.0	0.4	0.3	0.8	0.9
Placebo	0.4	1.0	0.6	0.6	0.2	0.4	0.4	0.5	0.8

Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 4

,,,

Intervention	units on a scale (Mean)
	Overall flushing	Redness	Warmth	Tingling	Itching
BG00012	4.4	3.8	4.0	3.4	3.2
BG00012 + ASA	2.4	1.6	2.3	1.6	1.3
BG00012 Slow Titration	5.6	5.1	5.2	4.0	4.3
Placebo	1.2	0.7	1.2	0.5	0.5

Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8

,,,

Intervention	units on a scale (Mean)
	Overall flushing	Redness	Warmth	Tingling	Itching
BG00012	3.8	3.6	3.9	3.3	3.1
BG00012 + ASA	3.3	2.9	3.1	2.3	2.3
BG00012 Slow Titration	3.1	2.9	2.9	2.2	1.8
Placebo	0.9	0.4	0.8	0.3	0.7

Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).

Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol. (NCT00256984)
Timeframe: Baseline, 6 months

Intervention	units on a scale (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	1.43

PAC QOL Patient Assessment of Constipation (Overall)

PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol (NCT00256984)
Timeframe: Baseline, 12 months

Intervention	units on a scale (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	0.95

Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure

The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure. (NCT00256984)
Timeframe: one year from Baseline

Intervention	percentage of change (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	60.8

Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure

Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol. (NCT00256984)
Timeframe: Baseline, 1 month post procedure

Intervention	percentage of change (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	-50.7

Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)

Intervention	percentage of change (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	-57.0

SF-12 QOL Change (Mental Component) at 12 Months From Baseline

SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure. (NCT00256984)
Timeframe: Baseline, 12 months

Intervention	units on a scale (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	4.83

SF-12 QOL Change From Baseline (Physical Component)at 12 Months

The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure. (NCT00256984)
Timeframe: Baseline, 12 Months

Intervention	units on a scale (Mean)
Stapled Trans-Anal Rectal Resection (STARR)	6.32

Reviews

1 review available for aspirin and Colonic Inertia

Article	Year
Late-breaking systematic reviews to inform evidence-based practice. Worldviews on evidence-based nursing, 2010, Volume: 7, Issue:3 Topics: Aspirin; Cardiac Rehabilitation; Cardiovascular Diseases; Constipation; Evidence-Based Practice; Hum	2010

Trials

2 trials available for aspirin and Colonic Inertia

Article	Year
Physical exercise, use of Plantago ovata and aspirin, and reduced risk of colon cancer. European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP), 2002, Volume: 11, Issue:5 Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Case-Control Studies; Colonic Neoplasms; Con	2002
Experimental observations on flufenamic, mefenamic, and meclofenamic acids. IV. Toleration by normal human subjects. Annals of physical medicine, 1966, Volume: Suppl Topics: Adult; Anti-Inflammatory Agents; Aspirin; Biphenyl Compounds; Blood Coagulation; Blood Urea Nitrogen	1966

Other Studies

7 other studies available for aspirin and Colonic Inertia

Article	Year
[An analysis of clinical characteristics and risk factors for ulceration in ischemic colitis]. Zhonghua nei ke za zhi, 2014, Volume: 53, Issue:8 Topics: Aged; Aspirin; Colitis, Ischemic; Constipation; Female; Gastrointestinal Hemorrhage; Hospitalization	2014
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. Clinical therapeutics, 2015, Jul-01, Volume: 37, Issue:7 Topics: Abdominal Pain; Adult; Aspirin; Constipation; Delayed-Action Preparations; Diarrhea; Dimethyl Fumara	2015
Risk factors for chronic constipation and a possible role of analgesics. Neurogastroenterology and motility, 2007, Volume: 19, Issue:11 Topics: Acetaminophen; Adult; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Chronic Disease;	2007
Abdominal bloating in employed adults: prevalence, risk factors, and association with other bowel disorders. The American journal of gastroenterology, 2008, Volume: 103, Issue:5 Topics: Adult; Aged; Aspirin; Colonic Diseases, Functional; Comorbidity; Constipation; Cross-Sectional Studi	2008
Functional constipation and outlet delay: a population-based study. Gastroenterology, 1993, Volume: 105, Issue:3 Topics: Adult; Aging; Alcohol Drinking; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Colon; Constipatio	1993
Functional constipation and outlet delay: a population-based study. Gastroenterology, 1993, Volume: 105, Issue:3 Topics: Adult; Aging; Alcohol Drinking; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Colon; Constipatio	1993
Functional constipation and outlet delay: a population-based study. Gastroenterology, 1993, Volume: 105, Issue:3 Topics: Adult; Aging; Alcohol Drinking; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Colon; Constipatio	1993
Functional constipation and outlet delay: a population-based study. Gastroenterology, 1993, Volume: 105, Issue:3 Topics: Adult; Aging; Alcohol Drinking; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Colon; Constipatio	1993
Drugs for pain. The Medical letter on drugs and therapeutics, 1998, Aug-14, Volume: 40, Issue:1033 Topics: Acetaminophen; Administration, Oral; Amitriptyline; Analgesics; Analgesics, Non-Narcotic; Analgesics	1998
Diseases of the alimentary system. Gastrointestinal reactions to drugs. British medical journal, 1976, Nov-13, Volume: 2, Issue:6045 Topics: Adrenal Cortex Hormones; Anti-Bacterial Agents; Aspirin; Constipation; Dyspepsia; Gastrointestinal D	1976