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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117051
Recruitment Status : Terminated (The study was stopped by the sponsor based on a non-safety related business priority decision)
First Posted : May 5, 2010
Results First Posted : June 26, 2013
Last Update Posted : June 12, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Non-cancer Pain Opioid Induced Constipation Drug: placebo Drug: prucalopride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Placebo Comparator: placebo
Drug: placebo

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

Primary Outcome Measures :
  1. 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 :
  1. Plasma Concentration of Prucalopride at Week 2 [ Time Frame: Week 2 ]
  2. Plasma Concentration of Prucalopride at Week 8 [ Time Frame: Week 8 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117051

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Leuven, Belgium
Sponsors and Collaborators
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Study Director: Marina Cools, Ph D Movetis
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Responsible Party: Shire Identifier: NCT01117051    
Other Study ID Numbers: M0001-C301
SPD555-301 ( Other Identifier: Shire Development LLC )
2009-015652-20 ( EudraCT Number )
First Posted: May 5, 2010    Key Record Dates
Results First Posted: June 26, 2013
Last Update Posted: June 12, 2014
Last Verified: April 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:
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Stress, Psychological
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs