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 | 6.0 |
E.1.2 | Classification code | 10010774 |
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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 |
To investigate the short-term efficacy of Transipeg in the treatment of constipation |
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E.2.2 | Secondary objectives of the trial |
Recording of adverse events |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· · Male and female patients · Normal diet (vegan or weight loss diet not acceptable) · Smoker of 10 cigarettes or less per day · Aged between 18 and 60 years · History of constipation for at least 3 months · Meet eligibility criteria for functional constipation (see below) · Acceptable medical history · Acceptable findings on physical examination · Acceptable vital signs · Acceptable results for haematology, clinical chemistry and urinalysis · Appropriate use of an effective method of contraception. The oral contraceptive pill is allowed (female patients only) · Negative pregnancy test (female patients only) · Ability to comprehend and communicate effectively with the Investigator and staff · Ability to give written informed consent
Diagnostic criteria for functional constipation: (adapted from Rome II criteria [4])Constipation for at least 3 months and at least one of the following:1. Less than 3 motions /week 2. Hard and/or lumpy stools requiring straining;3. Sensation of incomplete evacuationLoose stools are not present, there are insufficient criteria for IBS, and there are no symptoms suggestive of bowel cancer.
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E.4 | Principal exclusion criteria |
1· · Severe intractable constipation or faecal impaction · Medication which would interfere with study conduct or study assessments or which is commonly known to cause constipation · Positive alcohol test prior to dosing · Taking prescription-only laxatives (subjects using OTC-available products on a daily basis will be asked to stop medication 10 days prior to screening medical, subjects using OTC-available products less than 3 times per week will be asked to stop using these products at the time of recruitment/consenting). · Meeting criteria for IBS (see below) · Rectal bleeding or positive test for Faecal occult blood at screening · Recent weight loss or change in bowel habit · Known or suspected bowel perforation or risk of perforation, ileus or suspicion of intestinal obstruction · Prior GI surgery · Severe inflammatory bowel conditions (such as ulcerative colitis, Crohn's disease and toxic megacolon) and symptomatic stenosis · Painful abdominal symptoms of indeterminate cause · History of peptic ulcer (occasional heartburn or non-specific dyspepsia is acceptable). · Phenylketonuria · Sodium restricted diet (e.g. for heart failure or hypertension), reduced kidney function or controlled potassium diet · Hypersensitivity to the active substance or to any of the excipients of the product · Lactating/breastfeeding (female patients only)
Diagnostic criteria for IBSAt least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort and pain that has two of three features:1. Relieved with defecation; and/or2. Onset associated with change in frequency of stool3. Onset associated with change in form (appearance) of stool
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: Time to passage of first stool post initial dose |
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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 | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Blinded to Investigator and patient only |
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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.8.6 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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |