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A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

This study has been terminated.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 30, 2005
Last updated: November 30, 2006
Last verified: November 2006
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

Condition Intervention Phase
Adenomatous Polyposis Coli Drug: MK0966; rofecoxib / Duration of Treatment: 24 weeks Drug: Comparator: placebo / Duration of Treatment: 24 weeks Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number and average size of rectal polyps
  • Safety and tolerability

Secondary Outcome Measures:
  • Number and average size of duodenal polyps
  • Proportions of patients with improved overall colon rating

Estimated Enrollment: 62
Study Start Date: March 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females at least 18 years of age with familial adenomatous polyposis.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00140894

Canada, Quebec
Merck Frosst Canada Ltd.
Kirkland, Quebec, Canada, H9H3L1
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information Identifier: NCT00140894     History of Changes
Other Study ID Numbers: 2005_052
Study First Received: August 30, 2005
Last Updated: November 30, 2006

Keywords provided by Merck Sharp & Dohme Corp.:
Cancer Pain

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors processed this record on September 21, 2017