Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
Completed · Phase 1 · Has a placebo group
Conditions studied: Irritable Bowel Syndrome (IBS)
In brief
This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation
Key facts
- Study ID
- NCT00584298
- Run by
- Novartis
- People needed
- 50
- Starts
- 2008-01-01
- Last updated by the study team
- 2009-05-08
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Novartis Investigator Site — Boston, Massachusetts, United States
- Novartis Investigator Site — Rochester, Minnesota, 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
Full record on ClinicalTrials.gov
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