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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00276354
• Date of registration: 12/01/2006
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation
• Scientific 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.
• Date of first enrolment: December 1999
• Target sample size: 246
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00276354
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single.
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Constipation

Intervention(s)

Drug: PEG 4000 (Forlax ®)

Primary Outcome(s)

Digestive examination assessed at screening wash-out period and each month

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.

Nutritional status assessed at screening wash-out period, month 3 and month 6

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

Secondary Outcome(s)

Long term efficacy based on daily nurse diary

Healthcare cost analysis.

Secondary ID(s)

2-31-52072-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors