Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
TerminatedPhase 3NCT01117051
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Non-cancer Pain
- Opioid Induced Constipation
- Interventions
- Drug: placebo
- Drug: prucalopride
- Sponsor
- Shire
- Organization
- Takeda
- Start date
- 2010-05-19
- Primary completion
- 2012-08-13
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria to be assessed at screening: 1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years. 2. 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. 3. Subject is suffering from OIC (i.e. secondary to chronic opioid use). 4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication. Main exclusion criteria to be assessed at screening: 1. Constipation is thought to be drug-induced (except for opioids) 2. Disallowed medication is being used 3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy 4. Subject is suffering from secondary causes of chronic constipation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01117051