Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00140894
First received: August 30, 2005
Last updated: November 30, 2006
Last verified: November 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females at least 18 years of age with familial adenomatous polyposis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140894

Locations
Canada, Quebec
Merck Frosst Canada Ltd.
Kirkland, Quebec, Canada, H9H3L1
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140894     History of Changes
Other Study ID Numbers: 2005_052
Study First Received: August 30, 2005
Last Updated: November 30, 2006
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Rofecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 25, 2014