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

Phase 3

Terminated

• Conditions: Non-cancer Pain; Opioid Induced Constipation
• Interventions: Drug: placebo; Drug: prucalopride

• Registration Number: NCT01117051
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Study Start: 2010-05-19
• Primary Completion: 2012-08-13
• Study Completion: 2012-08-13
• Results First Submitted: 2013-04-02
• Results First Submitted QC: 2013-05-17
• Results First Posted: 2013-06-26
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
Resolor	prucalopride	prucalopride

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Prucalopride at Week 2	Week 2
Plasma Concentration of Prucalopride at Week 8	Week 8