E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010774 |
E.1.2 | Term | Constipation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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).
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will have ended for the participant after their final visit at the hospital at the end of week 10. The trial will therefore finish when all participants have completed the 3 periods(lasting 10 weeks)i.e last visit of last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |