Study Stopped
The study was stopped by the sponsor based on a non-safety related business priority decision
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
OIC
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
3 other identifiers
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedStudy Start
First participant enrolled
May 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2012
CompletedResults Posted
Study results publicly available
June 26, 2013
CompletedJune 11, 2021
May 1, 2021
2.2 years
April 29, 2010
April 2, 2013
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Plasma Concentration of Prucalopride at Week 2
Week 2
Plasma Concentration of Prucalopride at Week 8
Week 8
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo
Resolor
ACTIVE COMPARATORprucalopride
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Unknown Facility
Leuven, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the early termination of the study, results should be interpreted with caution.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 5, 2010
Study Start
May 19, 2010
Primary Completion
August 13, 2012
Study Completion
August 13, 2012
Last Updated
June 11, 2021
Results First Posted
June 26, 2013
Record last verified: 2021-05