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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00650598

Collaborator

(none)

328

Enrollment

Locations

Arms

Duration (Months)

13.1

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: valdecoxib Drug: diclofenac	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

328 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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 Procedure for Anterior Cruciate Ligament Reconstruction

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib 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
Active Comparator: Arm 2	Drug: diclofenac diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: valdecoxib

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

Active Comparator: Arm 2

Drug: diclofenac

diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Outcome Measures

Primary Outcome Measures

Patient Assessment of Pain - Visual Analogue Scale [Days 1-6]

Secondary Outcome Measures

Physical examination [Screening and Day 6]
Global Evaluation of Study Medication [Days 1-6]
Consumption of Rescue Medication [Days 1-6]
Modified Brief Pain Inventory - short form [Days 2-6]
Adverse events [Days 1-6]
Vital signs [Screening, Day 1, and Day 6]
Effect on Pain Medication Questionnaire and Health Resource Utilization [Days 2-6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Adelaide	South Australia	Australia	SA 5000
2	Pfizer Investigational Site	Hong Kong		Hong Kong
3	Pfizer Investigational Site	Shatin, New Territories		Hong Kong
4	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
5	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
6	Pfizer Investigational Site	Seoul		Korea, Republic of	140-757
7	Pfizer Investigational Site	Seoul		Korea, Republic of
8	Pfizer Investigational Site	Cheras	Kuala Lumpur	Malaysia	56000
9	Pfizer Investigational Site	Kuala Lumpur	Wilayah Persekutuan	Malaysia	50586
10	Pfizer Investigational Site	Kuala Lumpur	Wilayah Persekutuan	Malaysia	59100
11	Pfizer Investigational Site	Auckland		New Zealand
12	Pfizer Investigational Site	Christchurch		New Zealand
13	Pfizer Investigational Site	Wellington		New Zealand
14	Pfizer Investigational Site	Manila		Philippines
15	Pfizer Investigational Site	Quezon City		Philippines
16	Pfizer Investigational Site	Quezon		Philippines
17	Pfizer Investigational Site	Singapore		Singapore	529889
18	Pfizer Investigational Site	Kaohsiung		Taiwan
19	Pfizer Investigational Site	Keelung		Taiwan
20	Pfizer Investigational Site	Taipei		Taiwan
21	Pfizer Investigational Site	Bangkok		Thailand	10330
22	Pfizer Investigational Site	Bangkok		Thailand	10400
23	Pfizer Investigational Site	Bangkok		Thailand	10700
24	Pfizer Investigational Site	Bangkok		Thailand
25	Pfizer Investigational Site