Constipation Clinical Trial
Official title:
A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
Verified date | February 2008 |
Source | Movetis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine which dose of prucalopride is safe and effective
in patients with chronic constipation.
Hypothesis:
Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation
whereas 0,5 mg is a suboptimal dose.
Status | Completed |
Enrollment | 253 |
Est. completion date | April 1997 |
Est. primary completion date | April 1997 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18-70 years; 2. History of constipation, i.e., the subject reported the occurrence of two or more of the following criteria for at least 6 months before the selection visit: - two or fewer spontaneous* bowel movements a week, - lumpy (scyballae) and/or hard stools at least ¼ of the stools, - sensation of incomplete evacuation after at least ¼ of the stools, - straining at defaecation at least ¼ of the time. *The above criteria were only applicable for spontaneous bowel movements i.e., not preceded within a 24-hour period by the intake of a laxative agent. Subjects who never had a spontaneous bowel movement were considered constipated and eligible to enter the double-blind phase of the trial. 3. Constipation being severe and causing disability; the subject's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief; 4. Normal inhibition pattern of the external anal sphincter during straining i.e., relaxation of the m.puborectalis and a distal displacement of the rectal canal (digital examination and/or electromyographic and/or manometric evidence was acceptable); 5. Poor results with routine laxative treatment and diet counselling; 6. Constipation of a functional, i.e., idiopathic nature; 7. Written or oral witnessed informed consent; 8. Availability for follow-up during the trial period. Exclusion Criteria: 1. Constipation thought to be drug-induced; 2. Presence of secondary causes of constipation, i.e., subjects suffering from types or causes of constipation other than idiopathic constipation, for instance: endocrine disorders, metabolic disorders, or neurologic disorders; 3. Congenital megacolon/megarectum; 4. History of previous abdominal surgery (other than hysterectomy, surgery for Meckel's diverticle, appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy or fundoplication) thought to be the primary cause of constipation; 5. Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease; 6. Active proctological conditions thought to be responsible for the constipation; 7. Presence of the following ECG abnormalities: - 2nd or 3rd degree of AV-block, - prolonged QT-times (> 460 ms), - bradycardia; 8. Use of concomitant medication that might cause QT-prolongation; 9. Use of diuretics not associated with potassium sparing effects; 10. Known illnesses or conditions such as severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abused dependence but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders; 11. Impaired renal function; 12. Presence of a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT) concentration of > 2 times the normal limit; 13. Presence of clinically significant abnormalities of blood chemistry, other than those mentioned under 9-10, haematology or urinalysis at selection; 14. Pregnancy or wish to become pregnant during the trial. ; 15. Breast-feeding; 16. Investigational drug received in the 30 days preceding the trial; 17. Inability or unwillingness to return for required follow-up visits; 18. Reliability and physical state preventing proper evaluation of a drug 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 | Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo | 12 weeks | No | |
Secondary | Evaluation of the effects of R093877 on symptoms associated with chronic constipation | 12 weeks | No |
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