Study of Long-Term Use of Forlax® in Elderly Patients With Chronic Constipation
|ClinicalTrials.gov Identifier: NCT00276354|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : May 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: PEG 4000 (Forlax ®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||December 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276354
Show 146 Study Locations
|Study Director:||Philippe Garnier, MD||Ipsen|