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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139672
First received: August 29, 2005
Last updated: June 12, 2008
Last verified: June 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013