Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
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|ClinicalTrials.gov Identifier: NCT00276354|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: PEG 4000 (Forlax ®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 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|
|Actual Study Completion Date :||November 20, 2001|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276354
Show 146 Study Locations
|Study Director:||Ipsen Medical Director||Ipsen|