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COMPLETED Phase 3

Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

NCT00141193 · View on ClinicalTrials.gov ↗

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

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

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00141193

The ClinicalTrials.gov registry entry for NCT00141193 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,561 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00141193 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00141193?

The interventions under investigation include: Celecoxib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00141193?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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