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

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ClinicalTrials.gov Identifier: NCT00584298
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 8, 2009
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Drug: SMS995 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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.
Study Start Date : January 2008
Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: SMS995
Other Name: Octreotide, Sandostatin
Placebo Comparator: 2 Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. - colorectal compliance [ Time Frame: throughout the study ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584298

United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
Novartis Investigator Site
Rochester, Minnesota, United States, 55905
Novartis Investigator Site
Hamilton, Canada
Novartis Investigator Site
Gothenburg, Sweden
United Kingdom
Novartis Investigator Site
London, United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Novartis Investigator Site
Nottingham, United Kingdom
Sponsors and Collaborators
Principal Investigator: NOVARTIS Novartis investigator site
More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00584298     History of Changes
Other Study ID Numbers: CSMS995A2101
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 8, 2009
Last Verified: May 2009

Keywords provided by Novartis:

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Dilatation, Pathologic
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents