Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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
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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00276354

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

No publications provided 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:
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on November 25, 2014