Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Study Overview
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Brief Summary
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The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.

Official Title
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A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Conditions
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Non-cancer Pain, Opioid Induced Constipation

Intervention / Treatment
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* Drug: placebo
* Drug: prucalopride


Participation Criteria
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Eligibility Criteria
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Inclusion criteria to be assessed at screening: Male or non-pregnant, non-breast-feeding female outpatient ≥18 years. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1. Subject is suffering from OIC (i.e. secondary to chronic opioid use). Subject agrees to stop his/her laxative treatment and is willing to use rescue medication. Main exclusion criteria to be assessed at screening: Constipation is thought to be drug-induced (except for opioids) Disallowed medication is being used Subject was on chronic therapy for chronic constipation prior to start of opioid therapy Subject is suffering from secondary causes of chronic constipation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|
| Active Comparator: Resolor<br>prucalopride | Drug: prucalopride<br>* 1 or 2 mg prucalopride once daily before breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week | A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Prucalopride at Week 2 |  | Week 2 | 
| Plasma Concentration of Prucalopride at Week 8 |  | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid induced constipation/prucalopride chronic non-cancer pain, Subjects with chronic non-cancer pain suffering from OIC