A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

study id #: NCT00140894

condition: Adenomatous Polyposis Coli

status: terminated

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: August 6, 2002

estimated completion: Not Available

last updated: September 20, 2019

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:

exclusion criteria:

sponsor: Merck Sharp & Dohme Corp.

investigators: Medical Monitor, Merck Sharp & Dohme Corp.

trial center locations: Canada