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NCT00141193 · ClinicalTrials.gov registry record · Phase 3

Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

A Phase 3 study of Colorectal Adenoma, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
1,561
Enrollment target
20
Study locations

NCT00141193 is a Phase 3 study of Colorectal Adenoma that has completed, run by Pfizer. The registered enrollment target is 1,561 participants, above the 1,235-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT00141193, a Phase 3 study of Colorectal Adenoma, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
1,561 participants
Enrollment target
20
Study locations

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 Studied

Colorectal Adenoma

Interventions

  • DRUG Celecoxib

Study Locations (20)

Other

  • Pfizer Investigational Site - Brussels
  • Pfizer Investigational Site - Brussels
  • Pfizer Investigational Site - Brussels
  • Pfizer Investigational Site - Ghent

California

  • Pfizer Investigational Site - San Diego
  • Pfizer Investigational Site - San Kiego

Illinois

  • Pfizer Investigational Site - North Chicago
  • Pfizer Investigational Site - Oak Park

Maryland

  • Pfizer Investigational Site - Baltimore
  • Pfizer Investigational Site - Baltimore

Pennsylvania

  • Pfizer Investigational Site - Philadelphia
  • Pfizer Investigational Site - Philadelphia

Texas

  • Pfizer Investigational Site - Houston

Virginia

  • Pfizer Investigational Site - Richmond

Queensland

  • Pfizer Investigational Site - Townsville

Trial Details

FieldValue
Enrollment Target 1,561 participants
Start Date 2001-02
Est. Completion 2007-05
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT00141193

The ClinicalTrials.gov registry entry for NCT00141193 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,561 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,235-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (26% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Adenoma appearing as the primary indexed condition, and to 1 intervention - of which Celecoxib is the first listed.

NCT00141193 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00141193 about?

NCT00141193 is a clinical study titled "Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)". 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 admini...

What is the current status of trial NCT00141193?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,561 participants. The study started on 2001-02. Estimated completion is 2007-05.

What conditions does trial NCT00141193 study?

This clinical trial studies the following conditions: Colorectal Adenoma.

What interventions are being tested in trial NCT00141193?

The interventions under investigation include: Celecoxib (DRUG).

Who is sponsoring clinical trial NCT00141193?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00141193 being conducted?

This trial has 20 study locations across California, Illinois, Maryland, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.