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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276354
First Posted: January 13, 2006
Last Update Posted: May 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ipsen
  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
Intervention Model: Parallel Assignment
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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

ClinicalTrials.gov Identifier: NCT00276354     History of Changes
Other Study ID Numbers: 2-31-52072-003
First Submitted: January 12, 2006
First Posted: January 13, 2006
Last Update Posted: May 16, 2006
Last Verified: May 2006

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