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):
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.
Opioid Induced Constipation
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
Placebo Comparator: placebo
Active Comparator: Resolor
1 or 2 mg prucalopride once daily before breakfast
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion criteria to be assessed at screening:
- Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
- 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.
- Subject is suffering from OIC (i.e. secondary to chronic opioid use).
- Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.
Main exclusion criteria to be assessed at screening:
- Constipation is thought to be drug-induced (except for opioids)
- Disallowed medication is being used
- Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
- Subject is suffering from secondary causes of chronic constipation.
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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
||Marina Cools, Ph D
No publications provided
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
||June 6, 2014
||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:
ClinicalTrials.gov processed this record on August 01, 2014
Signs and Symptoms, Digestive
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents