Functional constipation MedDRA version: 11 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Interventions
Product Name: Naloxone Hydrochloride Sustained Release Gastro-resistant Capsule
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Naloxone Hydrochloride
CAS Number: 357084
Other
Sponsors
Norfolk and Norwich University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of nalcol (number of responders) when used as an adjunct to usual laxatives in the treatment of patients with refractory constipation as compared to a placebo group (i.e. Period 2). ;Secondary Objective: A number of secondary analyses will be perform to further assess the response to the Nalcol treatment: Comparison of stool frequency and type, laxative use, and questionnaire responses between treatment and placebo groups during Period 2 of the study. PAC-SYM will be used to provide an overall symptom score; but each component will also be analysed separately to identify changes to individual symptoms. Post trial transit studies will be undertaken in those patients who have previously undergone a transit study. These will be compared to determine an objective reduction in transit time. Effect of Nalcol on colonic bacterial populations through analysis of th stool samples. ;Primary end point(s): The primary outcome will be a comparison of the responders during Period 2 of the study (weeks 3-6) in the treatment group and those in the placebo group. Response is defined as those participants who give an assessment of ‘satisfactory improvement’ on at least 50% of occasions over the 4 week trial period (Period 2) to the global question on the diary card. | — |
Countries
United Kingdom
Outcome results
None listed