Study of Long-Term Use of Forlax® in Elderly Patients With Chronic Constipation
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:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||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.|
- 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
- Digestive examination assessed at screening wash-out period and each month
- Nutritional status assessed at screening wash-out period, month 3 and month 6
- 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.
- Drug interaction assessment assessed at screening wash-out period and month 3 and 6.
- Long term efficacy based on daily nurse diary
- Healthcare cost analysis.
|Study Start Date:||December 1999|
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|Study Director:||Philippe Garnier, MD||Ipsen|