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

May 19, 2021 updated by: Shire

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
placebo
ACTIVE_COMPARATOR: Resolor
prucalopride
Drug: prucalopride
1 or 2 mg prucalopride once daily before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
Time Frame: 12 weeks
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
Time Frame
Plasma Concentration of Prucalopride at Week 2
Time Frame: Week 2
Week 2
Plasma Concentration of Prucalopride at Week 8
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 19, 2010

Primary Completion (ACTUAL)

August 13, 2012

Study Completion (ACTUAL)

August 13, 2012

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 5, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M0001-C301
  • SPD555-301 (OTHER: Shire Development LLC)
  • 2009-015652-20 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Induced Constipation

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe