E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional crhonic constipation |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063582 |
E.1.2 | Term | Constipation chronic |
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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 evaluate the effect of a symbiotic a mixture of hyspaghula husk powder 2gr, plantago ovata variety, 99% of purity, and a mix of Lactobacillus acidophilus, plantarum, rhamnosus Bifidobacterium breve, longum for the treatment of chronic constipation due to colonic and rectal disfunction. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate: a)the reduction of the severity score index of constipation on the base of Agachan-Wexner score (DisColonRectum 1996; 39: 681-5) b)the improvement of the QoL evaluated with a specific questionnaire for the Functional disorders (Dig Dis Sci 1998; 43: 400-11). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
.obtaining the informed consense, .age >18 and <65 .Patients, for 3 years, fulfilling the Rome III criteria for Functional Constipation with/without obstructed defecation according Rome III criteria.Patients will be randomised in two groups assigned to either of the following treatment protocols. .A patological intestinal transit time evaluated with Metcalf e coll. methods over the normal range of 60 Hours for the ♂ and 70 hours per le ♀. |
|
E.4 | Principal exclusion criteria |
.age >65 or <18 years .have symptoms, particularly abdominal pain/disconfort, that are, according Rome III criteria, justified to an subtipe of IBS symptoms .the patients before 2 years had abdominal and proctological surgery, excluded appendectomy, hysterectomy, rubber band ligation and doppler band ligation. .at defecography the patients have a rectocele > 3 cm and/or a complete rectal prolapse[Dvorkin LS et al. Br J Surg 2005; 92: 866-72) .at proctological evaluation have a mucosal prolapse of third degree according Parks classification and/or anal fissures. .the patiens take on drugs promoting constipation that are not suspensible (calciumantagonists, nitroderivates,etc .presenting a patological results above 80% of the psycometric itemsabout illness behaviour: CES-D,SCL-90-R,IBQ . |
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E.5 End points |
E.5.1 | Primary end point(s) |
The improvement of the intestinal transit time, the frequency and the normalization of the evacuation rithms and fecal consistence according the Bristol Form scale. |
|
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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
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 | 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 | 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.8.4.1 | 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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |