E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
for bowel cleansing prior to any clinical procedure requiring a clean bowel, e.g, bowel endoscopy, lower gastrointestinal tract radiology or digestive tract surgery. |
|
MedDRA Classification |
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 |
Patients often have to take osmotic laxatives to prepare the colon for colonoscopy or barium enema. We are interested in how these work and whether taking the dose all at once or in divided doses will affect the water distribution in the small bowel. |
|
E.2.2 | Secondary objectives of the trial |
We are also interested in how this bowel cleansing alters the gut bacteria and gut function since this may be relevant to many patients with irritable bowel syndrome (IBS) who have disturbed bowel habit and altered gut bacteria. This study will use a laxative model of an episode of diarrhoea and we will use magnetic resonance imaging (MRI) to take images of the small bowel and the colon at intervals. We will also measure the bacteria present in the stools. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female healthy volunteers who are 18-65 years BMI 18-28 kg/m2 Able to give voluntary written informed consent to participate in the study Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
|
|
E.4 | Principal exclusion criteria |
Any history of serious acute or chronic illness especially gastrointestinal Diabetes Mellitus Pregnancy or breastfeeding Smoking Unsuitable for MRI scanning (i.e. have metal implants or pacemaker) Anyone taking regular medication interfering with gastrointestinal function including opiates or constipating drugs. Subjects using the combined oral contraceptive pill or progesterone only pill will be excluded if not prepared to use an alternative barrier method for the duration of the menstrual cycle following dosing with moviprep. Substance abuse Have taken part in any other clinical study within the previous 3 months Previous gastrointestinal surgery of any kind (excluding appendicectomy)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint: Effect of 1 & 2 litres of Moviprep on AUC small bowel water content 0-6 hours |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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
|
the end of the trial will be the last visit of the last subject |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |