Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2001-11-20
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

Inclusion Criteria:

• Institutionalized patients (in a medical care ward) for at least 3 months, or ambulatory patients

• Suffering from chronic constipation defined as:

• either less than 3 stools per week for at least 3 months and no or partial efficacy of dietary advices, OR

• patient treated with laxative medication/s for at least 3 months before inclusion, because of chronic constipation corresponding to less than 3 stools per week in case of no laxative treatment

• patient has less than 3 stools during 7 consecutive days of the screening wash-out period

Exclusion Criteria:

• known organic intestinal disease

• having had intestinal surgery

• abdominal or pelvic radiation, carcinoma, obstructive disease, malabsorption disease

• fecal mass in the rectum which cannot be completely evacuated during the screening wash-out period