NCT00598234

Brief Summary

We propose that administration perioperative celecoxib is effective to control postoperative VAS pain scores, improve rehabilitation results, and decrease narcotics usage in total knee replacement patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

September 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

2.9 years

First QC Date

January 10, 2008

Last Update Submit

June 20, 2010

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • VAS pain scores, range-of-motion, narcotics usage

    post-op 6hrs,12hrs,day1,day2,day3,day7

Study Arms (2)

1

ACTIVE COMPARATOR

Celecoxib (Celebrex)

Drug: Celecoxib (Celebrex)

2

PLACEBO COMPARATOR

Placebo

Drug: Celecoxib (Celebrex)

Interventions

Celecoxib (Celebrex)DRUG

The study group received 400mg oral celecoxib about 1 hr prior to surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients received Acetaminophen 500mg qid for pain control.

12

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving total knee replacement will be recruited in this study.

You may not qualify if:

  • subjects with end-stage renal disease, cerebral vascular accident, peptic ulcer, long-term usage of NSAIDs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ching-Chuan Jiang

Taipei, Taiwan

Location

Related Publications (1)

  • Huang YM, Wang CM, Wang CT, Lin WP, Horng LC, Jiang CC. Perioperative celecoxib administration for pain management after total knee arthroplasty - a randomized, controlled study. BMC Musculoskelet Disord. 2008 Jun 3;9:77. doi: 10.1186/1471-2474-9-77.

    PMID: 18519002DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ching-Chuan Jiang, M.D.;Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 21, 2008

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

TW(1)