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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276354

Enrollment

246

Registered

2006-01-13

Start date

1999-12-31

Completion date

2001-11-20

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

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.

Interventions

DRUGPEG 4000 (Forlax ®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	—
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	—
Nutritional status assessed at screening wash-out period, month 3 and month 6	—

Secondary

Measure	Time frame
Healthcare cost analysis.	—
Long term efficacy based on daily nurse diary	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026