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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00149877 |
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Date of registration:
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06/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
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Scientific title:
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Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00149877 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Novartis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Basel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and females of at least 18 years of age
- A 12-month history of constipation (defined as < three spontaneous bowel movements
per week and =1 of the following symptoms >25% of the time: hard stools, sensation of
incomplete evacuation and straining)
Exclusion Criteria:
- Patients with cancer, inflammatory bowel disease or other structural bowel disease
- Patients who participated in a prior tegaserod study
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or
neurological disorders
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Constipation
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Intervention(s)
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Drug: Tegaserod
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Primary Outcome(s)
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Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
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Secondary Outcome(s)
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Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
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Laxative use.
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Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
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Safety and tolerability.
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Number of csbm during 8 weeks of treatment.
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Secondary ID(s)
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CHTF919EHK01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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