Status:
COMPLETED
Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
Lead Sponsor:
Ipsen
Conditions:
Constipation
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2001
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00276354
Start Date
December 1 1999
End Date
November 20 2001
Last Update
July 26 2019
Active Locations (146)
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1
19 rue Jules Guesde
Abscon, France, 59215
2
Centre Saint Victor
Amiens, France, 80054
3
117 ter rue Jean Jaurès
Anzin, France, 59410
4
8 rue Jean Jaurès
Anzin, France, 59410