Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

• Status: Completed
• Trial end date: 1999-09-01
• 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 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

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

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

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.