Study to Assess the Effect Of Alosetron On Mucosal Blood Flow

Phase 4

Completed

• Conditions: Irritable Colon

• Registration Number: NCT00370032
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-30
• Study Start: 2006-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2009-03-02
• Results First Posted: 2009-04-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Left Colon Mucosal Blood Flow (MBF)	Day 6 after each treatment period	On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.

Secondary Outcome Measures

Name	Time	Method
Rectal Mucosal Blood Flow (MBF)	Day 6 after each treatment period	On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.
Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons	Day 6 after each treatment period	On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom