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

This study has been terminated.
(The study was stopped by the sponsor based on a non-safety related business priority decision)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01117051
First received: April 29, 2010
Last updated: June 6, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Non-cancer Pain
Opioid Induced Constipation
Drug: placebo
Drug: prucalopride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Plasma Concentration of Prucalopride at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo
Drug: placebo
placebo
Active Comparator: Resolor
prucalopride
Drug: prucalopride
1 or 2 mg prucalopride once daily before breakfast

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117051

Locations
Belgium
Leuven, Belgium
Sponsors and Collaborators
Shire
Investigators
Study Director: Marina Cools, Ph D Movetis
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01117051     History of Changes
Other Study ID Numbers: M0001-C301, SPD555-301, 2009-015652-20
Study First Received: April 29, 2010
Results First Received: April 2, 2013
Last Updated: June 6, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire:
Opioid induced constipation/prucalopride chronic non-cancer pain
Subjects with chronic non-cancer pain suffering from OIC

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014