Skip to main content
OpenTrials
Completed

NCT Number: NCT00633386

Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery

To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthroscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed knee meniscus pathology requiring ambulatory arthroscopic meniscectomy or partial meniscectomy
  • Willing to participate in study for 36 hours and come to follow-up visit 7 days post-surgery

Exclusion criteria

  • Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
  • Received acetaminophen or low-dose narcotic within 8 hours of surgery
  • Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or received intra-articular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Treatment and study plan

Celecoxib

Drug

400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery

Placebo

Other

Matched placebo

Primary outcomes

  1. Total analgesic use after surgery

    Time frame: 24 hours

Secondary outcomes

  1. Physical examination

    Time frame: Day 7

  2. Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery

    Time frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours

  3. Time to analgesic use after surgery

    Time frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours

  4. Cumulative number of HC/APAP tablets taken after first dose of study medication

    Time frame: 1, 2, 6, 8, 10, 12, 36 hours and Day 2

  5. Vital signs

    Time frame: Day 7

  6. Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery

    Time frame: 1, 2, 6, 8, 10, 12, 24 and 36 hours

  7. Change in volumetric measurement of both knees from prior to surgery

    Time frame: Day 7

  8. Patient Treatment Satisfaction Scales after surgery

    Time frame: 24 hours

  9. Adverse events

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Double-blind, Placebo-Controlled, Randomized, Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery

Important dates

Study start
2003
Study completion
2003
First posted
Mar 12, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.