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

Further Study Details: 

Primary Outcomes: To assess the effect of PD-217,014 on the relief of abdominal pain/discomfort; In patients To assess the effect of PD-217,014 on the relief of abdominal pain/discomfort; In patients with irritable bowel syndrome; The primary endpoint is a responder; Defined by having adequate relief of abdominal pain/discomfort; For more than or equal to 50% of; with irritable bowel syndrome; The primary endpoint is a responder; Defined by having adequate relief of abdominal pain/discomfort; For more than or equal to 50% of
Secondary Outcomes: - To assess the effect of PD-217,014 on the patient''''s global assessment of IBS symptoms (change from baseline to week4); - To assess the effect of PD-217,014 on stool frequency & consistency (change from baseline to week 4); - To assess the effect of PD-217
Expected Total Enrollment:  330

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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.

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A4451007
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139672
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13