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

This study has been completed.

First Received: December 21, 2007 Last Updated: May 7, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00584298

Purpose

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	Intervention	Phase
Irritable Bowel Syndrome (IBS)	Drug: SMS995 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
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.

Resource links provided by NLM:

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Novartis:

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. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- colorectal compliance [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	January 2008
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SMS995
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584298

Locations

United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
Novartis Investigator Site
Rochester, Minnesota, United States, 55905
Canada
Novartis Investigator Site
Hamilton, Canada
Sweden
Novartis Investigator Site
Gothenburg, Sweden
United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Novartis Investigator Site
Nottingham, United Kingdom
Novartis Investigator Site
London, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSMS995A2101
Study First Received:	December 21, 2007
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00584298 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Sweden: Medical Products Agency

Keywords provided by Novartis:

Barostat
distention
IBS
irritable
bowel

syndrome
colorectal
sensation
modulation
reproducibility

Study placed in the following topic categories:

Digestive System Diseases
Antineoplastic Agents, Hormonal
Dilatation, Pathologic
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Octreotide
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Disease
Antineoplastic Agents, Hormonal
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Gastrointestinal Agents
Octreotide
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Syndrome
Therapeutic Uses
Irritable Bowel Syndrome
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on September 10, 2009