- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00487422
Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation
A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients.
Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multicentre, randomised, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week, double-blind, placebo-controlled treatment period.
During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.
Subjects will be allowed to take a laxative (Dulcolax®) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group.
During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female subjects of 65 or over 65 years of age.
History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
- very hard (little balls) and/or hard stools at least a quarter of the stools
- sensation of incomplete evacuation following at least a quarter of the stools
- straining at defecation at least a quarter of the stools. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.
Exclusion Criteria:
- Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
- Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
- Subjects with the main complaint of abdominal pain.
- Subjects with a known megacolon/megarectum or a diagnosis of pseudo-obstruction.
- Constipation as a result of surgery.
- Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
- Malignancies or AIDS.
- Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included.
- Subjects with a serum creatinine concentration > 2 mg/dL (> 180 micromol/L).
- Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Prucalopride
|
2 mg o.d.
Other Names:
|
ACTIVE_COMPARATOR: 2
Prucalopride
|
4 mg o.d.
Other Names:
|
PLACEBO_COMPARATOR: 3
Placebo
|
o.d.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with an average of 3 or more SCBM per week
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary efficacy variables: 1)Symptom variables 2)QOL variables
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerald Demschik, M.D., Geriatriezentrum am Wienerwald
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRU-INT-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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