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NCT00584298 Clinical Trial

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

Irritable Bowel Syndrome (IBS) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584298
Other study ID # CSMS995A2101
Secondary ID
Status Completed
Phase Phase 1
First received December 21, 2007
Last updated May 7, 2009
Start date January 2008

Study information
Verified date May 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• SMS995

• Placebo

Locations
Country Name City State
Canada Novartis Investigator Site Hamilton
Sweden Novartis Investigator Site Gothenburg
United Kingdom Novartis Investigator Site London
United Kingdom Novartis Investigator Site Manchester
United Kingdom Novartis Investigator Site Nottingham
United States Novartis Investigator Site Boston Massachusetts
United States Novartis Investigator Site Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary - 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 No
Secondary - colorectal compliance throughout the study No
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