NCT00633438

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

First QC Date

March 4, 2008

Last Update Submit

February 18, 2021

Conditions

Arthroscopy

Keywords

Knee Surgery Arthroscopic Surgery

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (7)

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

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

  • Time to analgesic use after surgery

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

  • Number and percentage of patients taking HC/APAP after surgery

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

  • Adverse events

    Day 7

  • Physical exam

    Day 7

  • +2 more secondary outcomes

Study Arms (2)

B

PLACEBO COMPARATOR
Other: Placebo

A

EXPERIMENTAL
Drug: Celecoxib

Interventions

PlaceboOTHER

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

B
CelecoxibDRUG

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

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

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

Timonium, Maryland, 21093, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01104, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01109, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01199, United States

Location

Pfizer Investigational Site

Springfield, Missouri, 65807, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29202, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29204, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29212, United States

Location

Pfizer Investigational Site

Orangeburg, South Carolina, 29110, United States

Location

Pfizer Investigational Site

Johnson City, Tennessee, 37601, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78205, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78209, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78240, United States

Location

Related Links

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic 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

January 1, 2004

Study Completion

June 1, 2004

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(18)