Constipation Clinical Trial
Official title:
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.
Verified date | April 2013 |
Source | Movetis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether prucalopride is safe and effective in the
treatment of chronic constipation.
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 | 620 |
Est. completion date | May 1999 |
Est. primary completion date | May 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit). - 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 or 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 time. 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 a megacolon/megarectum or a diagnosis of pseudo-obstruction. - 4. Constipation as a result of surgery. - 5. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease. - 6. Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders. - 7. Subjects with impaired renal function. - 8. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. - 9. Females of child-bearing potential without adequate contraceptive protection during the trial. |
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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