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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00584298

Collaborator

(none)

Enrollment

Locations

Arms

7.1

Patients Per Site

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome (IBS)	Drug: SMS995 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Women With Irritable Bowel Syndrome to Evaluate Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide.

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: SMS995 Other Names: Octreotide, Sandostatin
Placebo Comparator: 2	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: SMS995

Other Names:

Octreotide, Sandostatin

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

- 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

- colorectal compliance [throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	Boston	Massachusetts	United States	02215
2	Novartis Investigator Site	Rochester	Minnesota	United States	55905
3	Novartis Investigator Site	Hamilton		Canada
4	Novartis Investigator Site	Gothenburg		Sweden
5	Novartis Investigator Site	London		United Kingdom
6	Novartis Investigator Site	Manchester		United Kingdom
7	Novartis Investigator Site	Nottingham		United Kingdom