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

August 29, 2005
June 12, 2008
January 2004
February 2005   (final data collection date for primary outcome measure)
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).
  • 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
Complete list of historical versions of study NCT00139672 on ClinicalTrials.gov Archive Site
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).
  • - 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
Not Provided
Not Provided
 
A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: PD-217,014
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
February 2005
February 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00139672
A4451007
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP