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.
1 other identifier
interventional
50
4 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedMay 8, 2009
May 1, 2009
1.2 years
December 21, 2007
May 7, 2009
Conditions
Keywords
Outcome Measures
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.
throughout the study
Secondary Outcomes (1)
- colorectal compliance
throughout the study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (7)
Novartis Investigator Site
Boston, Massachusetts, 02215, United States
Novartis Investigator Site
Rochester, Minnesota, 55905, United States
Novartis Investigator Site
Hamilton, Canada
Novartis Investigator Site
Gothenburg, Sweden
Novartis Investigator Site
London, United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Novartis Investigator Site
Nottingham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NOVARTIS
Novartis investigator site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 2, 2008
Study Start
January 1, 2008
Primary Completion
April 1, 2009
Last Updated
May 8, 2009
Record last verified: 2009-05