ALOXONE HYDROCHLORIDE SR GASTRO-RESISTANT SUSTAINED RELEASE CAPSULES AS A TREATMENT FOR FUNCTIONAL CONSTIPATION: A RANDOMISED, DOUBLE BLIND CONTROLLED TRIAL IN SECONDARY CARE - The use of Nalcol in functional constipatio
- Conditions
- Functional constipationMedDRA version: 11Level: LLTClassification code 10010774Term: Constipation
- Registration Number
- EUCTR2009-011853-42-GB
- Lead Sponsor
- orfolk and Norwich University Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria (all must be met)
Age > 18 years
Male or Female
Satisfy Rome III criteria for functional (slow transit) constipation
Symptoms not relieved by diet and laxatives
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Severe cardiac, renal or hepatic impairment
Severe psychiatric disturbance
Mental disorder preventing adequate informed consent
Dilatation of the bowel (megarectum or pseudo-obstruction)
Known pregnancy, suspected pregnancy, or trying to conceive
Currently participating (or within 1 month) in any other study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method