Constipation Digestive System Other functional intestinal disorders
Conditions
Interventions
This is a single-centre double-blind placebo-controlled study of the efficacy and safety of Nalcol™ given to patients with refractory constipation attending a specialist clinic. The study is principal
with no significant systemic side effects. It is known that 10 mg, twice a day is effective in increasing gut motility in normal subjects and a group of patients have taken 40 mg daily and occas
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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 3. A comparison of pre-treatment versus treatment symptom levels in the whole (n = 120), i.e., Period 1 versus Period 3 4. Comparison of stool bacterial counts between the treatment and placebo groups in the selected subset after each Period | — |
Countries
United Kingdom
Outcome results
None listed