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Completed

NCT Number: NCT00584298

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

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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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Dilatation, Pathologic Disease Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigator Site, Hamilton, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMS995

Drug

Other names: Octreotide, Sandostatin

Placebo

Drug

Primary outcomes

  1. - 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

Secondary outcomes

  1. - colorectal compliance

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
First posted
Jan 2, 2008
Registry last updated
May 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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