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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00584298

Enrollment

Registered

2008-01-02

Start date

2008-01-31

Completion date

Unknown

Last updated

2009-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Barostat, distention, IBS, irritable, bowel, syndrome, colorectal, sensation, modulation, reproducibility

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

Interventions

DRUGSMS995

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- colorectal compliance	throughout the study

Countries

Canada, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026