Constipation Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation
Verified date | June 2007 |
Source | Movetis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
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
Status | Completed |
Enrollment | 303 |
Est. completion date | September 1999 |
Est. primary completion date | September 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: 1. Male and female subjects of 65 or over 65 years of age. 2. 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: 1. very hard (little balls) and/or hard stools at least a quarter of the stools 2. sensation of incomplete evacuation following at least a quarter of the stools 3. 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: 1. Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication. 2. Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders. 3. Subjects with the main complaint of abdominal pain. 4. Subjects with a known megacolon/megarectum or a diagnosis of pseudo-obstruction. 5. Constipation as a result of surgery. 6. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease. 7. Malignancies or AIDS. 8. Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included. 9. Subjects with a serum creatinine concentration > 2 mg/dL (> 180 micromol/L). 10. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Movetis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with an average of 3 or more SCBM per week | 12 weeks | No | |
Secondary | Secondary efficacy variables: 1)Symptom variables 2)QOL variables | 12 weeks | No |
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