The use of Nalcol™ in functional constipatio
Phase 2
Completed
- Conditions
- ConstipationDigestive SystemOther functional intestinal disorders
- Registration Number
- ISRCTN26938218
- Lead Sponsor
- orfolk and Norwich University Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Aged greater than 18 years
2. Male or female
3. Satisfy Rome III criteria for functional (slow transit) constipation
4. Symptoms not relieved by diet and laxatives
Exclusion Criteria
1. Severe cardiac, renal or hepatic impairment
2. Severe psychiatric disturbance
3. Mental disorder preventing adequate informed consent
4. Dilatation of the bowel (megarectum or pseudo-obstruction)
5. Concomitant medication with drugs known to cause constipation
6. Known pregnancy, suspected pregnancy, or trying to conceive
7. Currently breastfeeding
8. Currently participating (or within 1 month) in any other study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 1. Comparison of stool frequency and type, laxative use, Patient Assessment of Constipation Symptoms (PAC-SYM), and Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) 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. Comparison will be made between the pre- and post-trial transit study as an objective marker of a reduction in transit time.<br>2. Graphical representation of the temporal changes in stool frequency and type and analysis to assess any drop-off of effect after 8 weeks of use in those receiving Nalcol™ for 8 weeks or in the whole group<br>3. A comparison of pre-treatment versus treatment symptom levels in the whole (n = 120), i.e., Period 1 versus Period 3<br>4. Comparison of stool bacterial counts between the treatment and placebo groups in the selected subset after each Period