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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139672

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: PD-217,014	Phase II

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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)

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Outcome Measures:

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).

Estimated Enrollment:	330
Study Start Date:	January 2004
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139672

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Study ID Numbers:	A4451007
Study First Received:	August 29, 2005
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00139672
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Abdominal Pain
Colonic Diseases

Irritable Bowel Syndrome
Pain
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009