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NCT00661635 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

A Phase 3 study of Pain and Laparoscopic Cholecystectomy, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
490
Enrollment target
20
Study locations

NCT00661635 is a Phase 3 study of Pain and Laparoscopic Cholecystectomy that has completed, run by Pfizer. The registered enrollment target is 490 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT00661635, a Phase 3 study of Pain and Laparoscopic Cholecystectomy, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
490 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

Conditions Studied

Pain Laparoscopic Cholecystectomy

Interventions

  • DRUG placebo
  • DRUG valdecoxib

Study Locations (20)

Arizona

  • Pfizer Investigational Site - Glendale
  • Pfizer Investigational Site - Glendale
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Phoenix
  • Pfizer Investigational Site - Tucson
  • Pfizer Investigational Site - Tucson
  • Pfizer Investigational Site - Tucson

Alabama

  • Pfizer Investigational Site - Birmingham
  • Pfizer Investigational Site - Daphne
  • Pfizer Investigational Site - Fairhope
  • Pfizer Investigational Site - Mobile
  • Pfizer Investigational Site - Mobile
  • Pfizer Investigational Site - Sheffield

California

  • Pfizer Investigational Site - Anaheim
  • Pfizer Investigational Site - Bakersfield
  • Pfizer Investigational Site - Bakersfield
  • Pfizer Investigational Site - Los Angeles
  • Pfizer Investigational Site - Los Angeles

Trial Details

FieldValue
Enrollment Target 490 participants
Start Date 2002-11
Est. Completion 2003-07
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00661635

The ClinicalTrials.gov registry entry for NCT00661635 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 303-participant average among 374 other Pain trials with a reported enrollment target (62% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00661635 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT00661635 about?

NCT00661635 is a clinical study titled "A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain". To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

What is the current status of trial NCT00661635?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2002-11. Estimated completion is 2003-07.

What conditions does trial NCT00661635 study?

This clinical trial studies the following conditions: Pain, Laparoscopic Cholecystectomy.

What interventions are being tested in trial NCT00661635?

The interventions under investigation include: placebo (DRUG), valdecoxib (DRUG).

Who is sponsoring clinical trial NCT00661635?

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

Where is trial NCT00661635 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. 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

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.