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Pain Relief In Irritable Bowel Syndrome — PRITON  

Irritable Bowel Syndrome Clinical Trial

Official title:
Efficacy of Proklama on Patients' Symptoms With Irritable Bowel Syndrome: Clinical Trial, Double- Blind, Crossover, Controlled Study vs. Placebo

Clinical Trial Summary

The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.

Clinical Trial Description

This is a phase IV, double- blind, randomized, placebo controlled, monocentric study. Males and women over 18 y.o. with Irritable bowel syndrome (IBS) diagnosed applying Rome III criteria will be enrolled consecutively. The study consist of 4 periods: - A screening's period of 2 weeks starting from visit 1, useful to screen potentially eligible patients performing diagnostic investigations necessary to confirm diagnosis. - A run- in's period, starting from visit 2 and lasting 2 weeks will represent a baseline without specific treatments in order to characterize the severity of symptomatology and evaluate patients' compliance relative to daily diaries - A 2 weeks- treatment's period ( active/ placebo) starting from visit 3. The 1st day of the period of treatment, eligible patients will be randomized following a 1:1 ratio to receive Proklama ( 1 sachet/ day) or placebo. Treatments will be administered daily during the whole 2 weeks- treatment's period. - A wash out's period lasting 2 weeks starting from visit 4, to be performed the day after the end of the 2 weeks- treatment's period. - A 2 weeks- treatment's period ( placebo/ active) starting from visit 5, to be performed the last day of wash out's period. During this visit patients will receive the second treatment, following a crossover design. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02573844
Study type Interventional
Source Geophyt S.r.l.s.
Contact
Status Completed
Phase Phase 4
Start date January 2015
Completion date June 2018
View Details
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