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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00584298
• Date of registration: 21/12/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis
• Public title: Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
• Scientific 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.
• Date of first enrolment: January 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00584298
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

Canada, Sweden, United Kingdom, United States

Contacts

• Name: NOVARTIS
• Affiliation: Novartis investigator site

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome (IBS)

Intervention(s)

Drug: Placebo

Drug: SMS995

Primary Outcome(s)

- 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(s)

- colorectal compliance [Time Frame: throughout the study]

Secondary ID(s)

CSMS995A2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors