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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):
Shire Identifier:
First received: April 29, 2010
Last updated: June 6, 2014
Last verified: April 2014
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
  • Plasma Concentration of Prucalopride at Week 8 [ Time Frame: Week 8 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01117051

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

Responsible Party: Shire Identifier: NCT01117051     History of Changes
Other Study ID Numbers: M0001-C301
SPD555-301 ( Other Identifier: Shire Development LLC )
2009-015652-20 ( EudraCT Number )
Study First Received: April 29, 2010
Results First Received: April 2, 2013
Last Updated: June 6, 2014

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:
Stress, Psychological
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 18, 2017