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

NCT00633386 | Completed Phase 4

• 1 other identifier: A3191066
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Arthroscopy

Keywords

Knee Surgery; Arthroscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Total analgesic use after surgery

  24 hours

Secondary Outcomes (9)

• Physical examination

  Day 7

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

  1, 2, 6, 8, 10, 12, 24, and 36 hours

• Time to analgesic use after surgery

  1, 2, 6, 8, 10, 12, 24, and 36 hours

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

  1, 2, 6, 8, 10, 12, 36 hours and Day 2

• Vital signs

  Day 7

Study Arms (2)

A

EXPERIMENTAL

Drug: Celecoxib

B

PLACEBO COMPARATOR

Other: Placebo

Interventions

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

A

Placebo OTHER

Matched placebo

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (9)

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33713, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21218, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01199, United States

Location

Pfizer Investigational Site

Springfield, Missouri, 65804, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29204, United States

Location

Pfizer Investigational Site

Johnson City, Tennessee, 37601, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, 22908-0159, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2003
• Study Completion: August 1, 2003
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

US (9)