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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Octreotide

Criteria

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.