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)
Information provided by (Responsible Party):
Movetis Identifier:
First received: April 29, 2010
Last updated: May 17, 2013
Last verified: May 2013

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 Movetis:

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
Drug: placebo
Active Comparator: Resolor
Drug: prucalopride
1 or 2 mg prucalopride once daily before breakfast


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

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
Please refer to this study by its identifier: NCT01117051

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

No publications provided

Responsible Party: Movetis Identifier: NCT01117051     History of Changes
Other Study ID Numbers: M0001-C301, SPD555-301
Study First Received: April 29, 2010
Results First Received: April 2, 2013
Last Updated: May 17, 2013
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 Movetis:
Opioid induced constipation/prucalopride chronic non-cancer pain
Subjects with chronic non-cancer pain suffering from OIC

Additional relevant MeSH terms:
Stress, Psychological
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants processed this record on April 17, 2014