Page last updated: 2024-10-25

clonidine and Nociceptive Pain

clonidine has been researched along with Nociceptive Pain in 4 studies

Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.
clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.

Nociceptive Pain: Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN.

Research

Studies (4)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's4 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Chabot-Doré, AJ1
Millecamps, M1
Naso, L1
Devost, D1
Trieu, P1
Piltonen, M1
Diatchenko, L1
Fairbanks, CA1
Wilcox, GL1
Hébert, TE1
Stone, LS1
Campbell, CM1
Kipnes, MS1
Stouch, BC1
Brady, KL1
Kelly, M1
Schmidt, WK1
Petersen, KL1
Rowbotham, MC1
Campbell, JN1
Sindrup, SH1
Finnerup, NB1
Jensen, TS1
Dworkin, RH1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy[NCT00695565]Phase 2180 participants (Actual)Interventional2008-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation

"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)." (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-7.9
Clonidine Topical Gel (ARC-4558)-9.6

Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation

"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.~The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement." (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-15.1
Clonidine Topical Gel (ARC-4558)-17.3

Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)

Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel17.7
Clonidine Topical Gel (ARC-4558)19.2

Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)

The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-0.6
Clonidine Topical Gel (ARC-4558)-1.1

Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)

The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-0.4
Clonidine Topical Gel (ARC-4558)-0.9

Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score

The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief). (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-7.3
Clonidine Topical Gel (ARC-4558)-8.7

Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionunits on a scale (Mean)
Placebo Gel-2.1
Clonidine Topical Gel (ARC-4558)-2.5

Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionpercentage of subjects (Number)
Placebo Gel47
Clonidine Topical Gel (ARC-4558)52

Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionpercentage of subjects (Number)
Placebo Gel32
Clonidine Topical Gel (ARC-4558)37

Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Clonidine Topical Gel (ARC-4558)-0.7-1.0-1.5-1.6-1.7-1.8-2.1-2.2-2.3-2.4-2.3-2.4
Placebo Gel-0.6-1.0-1.2-1.5-1.7-1.8-1.8-1.9-1.9-1.9-1.9-1.9

Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.~The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)

,
Interventionunits on a scale (Mean)
All subjectsCapsaicin response ≥ 2
Clonidine Topical Gel (ARC-4558)-2.4-2.7
Placebo Gel-1.9-1.5

Change in Blood Pressure From Baseline to Week 12

Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment. (NCT00695565)
Timeframe: Baseline and Week 12

,
InterventionmmHg (Mean)
Change in Systolic BPChange in Diastolic BP
Clonidine Topical Gel (ARC-4558)1.01.0
Placebo Gel-0.4-0.2

Clinician Global Impression of Change (CGIC) at Week 12

At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse. (NCT00695565)
Timeframe: Week 12

,
Interventionpercentage of subjects (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseVery Much Worse
Clonidine Topical Gel (ARC-4558)16.530.624.727.11.20
Placebo Gel5.838.427.925.62.30

Patient Global Impression of Change (PGIC) at Week 12

At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse. (NCT00695565)
Timeframe: Week 12

,
Interventionpercentage of subjects (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseVery Much Worse
Clonidine Topical Gel (ARC-4558)21.227.128.222.41.20
Placebo Gel11.832.931.821.21.21.2

Trials

1 trial available for clonidine and Nociceptive Pain

ArticleYear
Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy.
    Pain, 2012, Volume: 153, Issue:9

    Topics: Administration, Cutaneous; Aged; Analgesics; Capsaicin; Clonidine; Diabetic Neuropathies; Double-Bli

2012

Other Studies

3 other studies available for clonidine and Nociceptive Pain

ArticleYear
Dual allosteric modulation of opioid antinociceptive potency by α2A-adrenoceptors.
    Neuropharmacology, 2015, Volume: 99

    Topics: Adrenergic alpha-2 Receptor Agonists; Allosteric Regulation; Analgesics, Opioid; Animals; Clonidine;

2015
Tailored treatment of peripheral neuropathic pain.
    Pain, 2012, Volume: 153, Issue:9

    Topics: Analgesics; Clonidine; Diabetic Neuropathies; Female; Humans; Male; Nociceptive Pain

2012
Mechanism-based treatment of pain.
    Pain, 2012, Volume: 153, Issue:11

    Topics: Analgesics; Animals; Clonidine; Diabetic Neuropathies; Female; Humans; Male; Nervous System Diseases

2012