Back to resultsPrucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation (OIC)
Primary Purpose
Non-cancer Pain, Opioid Induced Constipation
Status
Terminated
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
placebo
prucalopride
Sponsored by
About this trial
This is an interventional treatment trial for Non-cancer Pain focused on measuring Opioid induced constipation/prucalopride chronic non-cancer pain, Subjects with chronic non-cancer pain suffering from OIC
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
Resolor
Arm Description
placebo
prucalopride
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plasma Concentration of Prucalopride at Week 2
Plasma Concentration of Prucalopride at Week 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01117051
Brief Title
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Acronym
OIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped by the sponsor based on a non-safety related business priority decision
Study Start Date
May 19, 2010 (Actual)
Primary Completion Date
August 13, 2012 (Actual)
Study Completion Date
August 13, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cancer Pain, Opioid Induced Constipation
Keywords
Opioid induced constipation/prucalopride chronic non-cancer pain, Subjects with chronic non-cancer pain suffering from OIC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Resolor
Arm Type
Active Comparator
Arm Description
prucalopride
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
prucalopride
Intervention Description
1 or 2 mg prucalopride once daily before breakfast
Primary Outcome Measure Information:
Title
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
Description
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Plasma Concentration of Prucalopride at Week 2
Time Frame
Week 2
Title
Plasma Concentration of Prucalopride at Week 8
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
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