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Completed

NCT Number: NCT00276354

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

19 rue Jules Guesde, Abscon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG 4000 (Forlax ®)

Drug

Primary outcomes

  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 outcomes

  1. Long term efficacy based on daily nurse diary

  2. Healthcare cost analysis.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Important dates

Study start
1999
Study completion
2001
First posted
Jan 13, 2006
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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