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

Novartis

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Drug: Placebo; Drug: SMS995

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584298

CSMS995A2101

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: SMS995

2

Placebo Comparator group

Treatment:

Drug: Placebo