Clinical Trials Logo
  1. Home
  2. Irritable Bowel Syndrome
  3. NCT00139672
  4. Details
NCT00139672 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139672
Other study ID # A4451007
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2005
Last updated June 12, 2008
Start date January 2004
Est. completion date February 2005

Study information
Verified date June 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• PD-217,014

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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).
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3