CClinicalTrials.gg
CompletedNCT00139672Updated Jun 17, 2008

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

A Phase 2 interventional study of PD-217,014 in Irritable Bowel Syndrome, sponsored by Pfizer. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 330 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient with an organic gastrointestinal disease.
  • Patients with poor renal function.
  • Patients with severe constipation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
330 participants

Interventions

  • DrugPD-217,014
06

What researchers measure

Primary outcomes

  1. 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

  1. 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).

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00139672
Lead sponsor
Pfizer
First posted
Aug 31, 2005
Start date
Jan 2004
Primary completion
Feb 2005
Completion
Feb 2005
Last update
Jun 17, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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