Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

NCT00141193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1561

Last updated 2008-08-06

No results posted yet for this study

Summary

This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

Conditions

  • Colorectal Adenoma

Interventions

DRUG

Celecoxib

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Peru
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom
  • Uruguay

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00141193 on ClinicalTrials.gov