Study of Long-Term Use of Forlax® in Elderly Patients With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276354
First received: January 12, 2006
Last updated: May 15, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: PEG 4000 (Forlax ®)
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Long term efficacy based on daily nurse diary
  • Healthcare cost analysis.

Estimated Enrollment: 240
Study Start Date: December 1999
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276354

  Show 146 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Philippe Garnier, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00276354     History of Changes
Other Study ID Numbers: 2-31-52072-003
Study First Received: January 12, 2006
Last Updated: May 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014