Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

• Status: Completed
• Trial end date: 1999-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

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.