Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Drug: SMS995; Drug: Placebo

• Registration Number: NCT00584298
• Lead Sponsor: Novartis

Brief Summary

This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study Start: 2008-01
• Study First Posted: 2008-01-02
• Primary Completion: 2009-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-07
• Last Update Posted: 2009-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• A positive diagnosis of IBS.
• Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
• contraception.
• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent

Exclusion Criteria

• History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
• Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
• Evidence of occult blood at stool analysis, or history of rectal bleeding.
• Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SMS995	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
- 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.	throughout the study

Secondary Outcome Measures

Name	Time	Method
- colorectal compliance	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇬🇧 Nottingham, United Kingdom