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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT01424228 |
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Date of registration:
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25/08/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged = 18 Years
SPD555-401 |
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Scientific title:
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A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged =18 Years With Chronic Constipation |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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364 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01424228 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Czech Republic
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Hungary
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Italy
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Poland
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Romania
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Slovakia
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Spain
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Sweden
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subject is a male or non-pregnant, non-breastfeeding female out-patient =18 years of
age (no upper age limit).
2. Subject has a history of constipation. The subject reports an average of =2 SBM/week
that result in a feeling of complete evacuation (SCBM).
3. Subject agrees to stop his/her current laxative treatment and is willing to use
rescue medication according to the rescue rule [bisacodyl/enemas].
Exclusion Criteria:
1. Subjects in whom constipation is thought to be drug-induced
2. Subjects using any disallowed medication.
3. Subjects who previously used prucalopride.
4. Subjects suffering from secondary causes of chronic constipation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Constipation
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Intervention(s)
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Drug: placebo
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Drug: prucalopride
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Primary Outcome(s)
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As a measure of efficacy: the primary endpoint is defined as the proportion (%) of subjects with an average of =3 SCBM /week evaluated over the 24-week treatment phase
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Quality of Life
[Time Frame: 24 weeks]
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Safety and tolerability
[Time Frame: 24 weeks]
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Secondary ID(s)
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M0001-C401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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