A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) | FAPvoice

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terminated

A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

study id #: NCT00140894

condition: Adenomatous Polyposis Coli

status: Terminated

purpose:

A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

intervention:
Drug: MK0966; rofecoxib / Duration of Treatment: 24 weeks
Drug: Comparator: placebo / Duration of Treatment: 24 weeks

start date: March 2003

estimated completion: Not Available

last updated: November 30, 2006

phase of development: Phase 4

size / enrollment: 62

study design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

primary outcomes:

  • Number and average size of rectal polyps
  • Safety and tolerability

secondary outcomes:

  • Number and average size of duodenal polyps
  • Proportions of patients with improved overall colon rating

inclusion criteria:
- Males or females at least 18 years of age with familial adenomatous polyposis.

exclusion criteria:

sponsor: Merck Sharp & Dohme Corp.

investigators: Medical Monitor, Merck Sharp & Dohme Corp.

locations: Canada