Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome

NCT00385099 | Completed Phase 2

• 1 other identifier: CRI103143
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.

Conditions

Irritable Colon

Keywords

IBS; stress; CRF1

Outcome Measures

Primary Outcomes (2)

• Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)

  Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue. Participants were examined in the left lateral position where DRT4 laser Doppler flow meter was placed against the rectal mucosa 10 centimeter (cm) above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius. Physiological stress was evoked using the cold water pressor test. Participants were asked to place their hand and forearm into a container of ice-cold water at 0-4degree Celsius and were persuaded to maintain that position for as long as possible during the stress period of 10 minutes. Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.

  Baseline (pre-dose) and Study Days 1, 2 and 3

• Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test)

  Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue, an indirect measure of flow can be obtained. Participants were examined in the left lateral position with no prior bowel preparation. The laser Doppler probe (DRT4 laser Doppler flow meter) was then placed against the rectal mucosa 10 centimeter above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius. The dichotomous listening test was used as a psychological stressor. At the onset of stress, folk music was played into one ear and rock music into the other ear for 10 minutes. Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods. Baseline was defined as the pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.

  Baseline (pre-dose) and Study Days 1, 2 and 3

Secondary Outcomes (9)

• Number of participants with adverse events (AE) and serious adverse events (SAE)

  Up to Week 14

• Number of participants with abnormal clinical chemistry data of clinical concern

  Up to Week 14

• Number of participants with abnormal hematology data of clinical concern

  Up to Week 14

• Participant perceived stress as assessed by a Visual Analogue Scale

  Study Days 1, 2 and 3

• Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP)

  Up to Week 14

Interventions

GW876008 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have irritable bowel syndrome.

You may not qualify if:

• Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

GW 876008

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: December 8, 2006
• Primary Completion: October 15, 2007
• Study Completion: October 15, 2007
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

GB (1)