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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139672

Enrollment

330

Registered

2005-08-31

Start date

2004-01-31

Completion date

2005-02-28

Last updated

2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief 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.

Interventions

DRUGPD-217,014

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026