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Sponsored by: |
Rikshospitalet HF |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00844727 |
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.
Condition | Intervention | Phase |
---|---|---|
Duodenal Polyposis |
Drug: Rofecoxib Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment |
Official Title: | Coxib-Inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis |
Enrollment: | 38 |
Study Start Date: | September 2003 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Rofexocib 25 mg OD, 1 year treatment
|
Drug: Rofecoxib |
2: Placebo Comparator
Placebo
|
Drug: placebo
placebo pills
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RH01/01 |
Study First Received: | February 13, 2009 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00844727 History of Changes |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
Familial Polyposis Digestive System Neoplasms Adenomatous Polyposis Coli Gastrointestinal Diseases Familial Adenomatous Polyposis Colonic Diseases Polyps Intestinal Diseases Intestinal Neoplasms Neoplastic Syndromes, Hereditary |
Digestive System Diseases Genetic Diseases, Inborn Rofecoxib Gastrointestinal Neoplasms Adenoma Colonic Neoplasms Adenomatous Polyps Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Intestinal Polyposis Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Adenomatous Polyposis Coli Colonic Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Digestive System Diseases |
Neoplasms by Site Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Gastrointestinal Neoplasms Adenoma Colonic Neoplasms Adenomatous Polyps Colorectal Neoplasms Neoplasms, Glandular and Epithelial |