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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

SMS995

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SMS995

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Octreotide, Sandostatin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No