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

Pfizer330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

330

Conditions

Irritable Bowel Syndrome

Interventions

PD-217,014DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

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).

Data from ClinicalTrials.gov

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