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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
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: PEG 4000 (Forlax ®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
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.
Study Start Date : December 1999
Actual Study Completion Date : November 20, 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation




Primary Outcome Measures :
  1. 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
  2. Digestive examination assessed at screening wash-out period and each month
  3. Nutritional status assessed at screening wash-out period, month 3 and month 6
  4. 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.
  5. Drug interaction assessment assessed at screening wash-out period and month 3 and 6.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
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

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
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00276354     History of Changes
Other Study ID Numbers: 2-31-52072-003
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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