A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females having Irritable bowel syndrome as defined by the Rome II criteria.
Patients must have had normal examination of colon anatomy within the last 5 years

Exclusion criteria

Patient with an organic gastrointestinal disease.
Patients with poor renal function.
Patients with severe constipation.

Treatment and study plan

PD-217,014

Drug

Primary outcomes

Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).

Secondary outcomes

Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Investigate The Effect Of Pd-217,014 In Patients With Irritable Bowel Syndrome (IBS)

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 31, 2005
Registry last updated: Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed