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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00276354

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 IV

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:

MedlinePlus related topics: Constipation

U.S. FDA Resources

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 - French Health Products Safety Agency

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012