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

Phase 4

Completed

• Conditions: Constipation

• Registration Number: NCT00276354
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Study Completion: 2001-11-20
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nutritional status assessed at screening wash-out period, month 3 and month 6
Digestive examination assessed at screening wash-out period and each month
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
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.

Secondary Outcome Measures

Name	Time	Method
Long term efficacy based on daily nurse diary
Healthcare cost analysis.

Trial Locations

Locations (145)

19 rue Jules Guesde; 🇫🇷 Abscon, France

Centre Saint Victor; 🇫🇷 Amiens, France

117 ter rue Jean Jaurès; 🇫🇷 Anzin, France

8 rue Jean Jaurès; 🇫🇷 Anzin, France

26 av. Charles de Gaulle; 🇫🇷 Aubevoye, France

89 avenue de Niort; 🇫🇷 Beauvoir Sur Niort, France

11 Place de la République; 🇫🇷 Blois, France

39, avenue de France; 🇫🇷 Blois, France

30 rue Bayeux; 🇫🇷 Bretteville l'Orgueilleuse, France

30 rue Pasteur; 🇫🇷 Bruille Les Marchiennes, France

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