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

Ipsen

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: PEG 4000 (Forlax ®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00276354

2-31-52072-003

Details and patient eligibility

About

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.

Enrollment

246 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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