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OpenTrials
Completed

NCT Number: NCT00633438

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

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

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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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

  • Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
  • Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion criteria

Exclusion criteria

  • Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
  • Received acetaminophen or low dose narcotic (vicodin/tylox) 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 intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Treatment and study plan

Placebo

Other

Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed

Celecoxib

Drug

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

Primary outcomes

  1. Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery

    Time frame: 24 hours

Secondary outcomes

  1. Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion

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

  2. Time to analgesic use after surgery

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

  3. Number and percentage of patients taking HC/APAP after surgery

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

  4. Adverse events

    Time frame: Day 7

  5. Physical exam

    Time frame: Day 7

  6. Vital signs

    Time frame: Day 7

  7. Laboratory evaluation

    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
2004
Study completion
2004
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.

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