Evaluation of symbiotic effect on the intestinal function in idiopathic chronic constipation. Multicenter, randomised, cross-over, double-blind, placebo-controlled study - ND
- Conditions
- CIdiopathic chronic constipationMedDRA version: 8.1Level: LLTClassification code 10010774Term: Constipation
- Registration Number
- EUCTR2006-001896-39-IT
- Lead Sponsor
- SOFAR SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 18-70 aged patients - idiopathic chronic constipation, diagnosed with Rome II criteria - slow intestinal transit time - written informed consens
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- previous gastro-intestinal surgery - endocrine diseases - neurological and muscular diseases - treatment with drugs potentially able to modify intestinal motility - intolerance of study product - significative clinical diseases - malicious neoplasia - patient unreliability - pregnant women - previous partecipation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the symbiotic ability to improve the patient intestinal function and to reduce constipation;Secondary Objective: - to evaluate the ability to reduce intestinal transit time in constipated patients - to evaluate the quality of life - to verify the treatment tolerability;Primary end point(s): Not applicable
- Secondary Outcome Measures
Name Time Method