Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 246
- Locations
- 291
- Primary Endpoint
- Nutritional status assessed at screening wash-out period, month 3 and month 6
Study Overview
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 digestive and nutritional status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Nutritional status assessed at screening wash-out period, month 3 and month 6
Digestive examination assessed at screening wash-out period and each month
Drug interaction assessment assessed at screening wash-out period and month 3 and 6.
Clinical and biological tolerance with special attention to digestive and nutritional status. Clinical tolerance will be assessed by digestive symptomatology collected on a daily basis
Vital signs assessed at screening wash-out period, month 3 and month 6. Biological tolerance will be assessed by nutritional markers, malabsorption markers and routine laboratory tests assessed at screening wash-out period and month 3 and 6.
Secondary Outcomes
- Long term efficacy based on daily nurse diary
- Healthcare cost analysis.