A Multicentre, Double-Blind, Double-Dummy, Randomised Stu... | NCT00650598

Studies
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

NCT00650598

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 8, 2008Estimated

Enrollment

328Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

valdecoxib
diclofenac

Countries

Australia
Hong Kong
Malaysia
New Zealand
Philippines
Singapore
South Korea
Taiwan
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2008

Last Update Posted Date

Oct 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

328Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Drug: valdecoxib
Arm 2	Active Comparator		Drug: diclofenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
valdecoxib	Drug	valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Assessment of Pain - Visual Analogue Scale		Days 1-6

Secondary Outcomes

Measure	Description	Time Frame
Physical examination		Screening and Day 6
Global Evaluation of Study Medication		Days 1-6
Consumption of Rescue Medication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included

Exclusion Criteria:

Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
The patient was undergoing bilateral knee arthroscopy
The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
The patient received oxaprozin or piroxicam within one week prior to randomization
The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Adelaide	South Australia	SA 5000	Australia
Pfizer Investigational Site

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals