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 | Completed Phase 4

• 1 other identifier: A3471039
• Study Type: interventional
• Target: 328
• Locations: 9 countries
• Sites: 24

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.

Conditions

Pain, Postoperative

Keywords

anterior cruciate ligament, arthroscopy, knee, post-surgical pain

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Pain - Visual Analogue Scale

  Days 1-6

Secondary Outcomes (7)

• 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: diclofenac

Interventions

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

diclofenac DRUG

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

Arm 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Pfizer Investigational Site

Adelaide, South Australia, SA 5000, Australia

Location

Pfizer Investigational Site

Hong Kong, Hong Kong

Location

Pfizer Investigational Site

Shatin, New Territories, Hong Kong

Location

Pfizer Investigational Site

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Pfizer Investigational Site

Auckland, New Zealand

Location

Pfizer Investigational Site

Christchurch, New Zealand

Location

Pfizer Investigational Site

Wellington, New Zealand

Location

Pfizer Investigational Site

Manila, Philippines

Location

Pfizer Investigational Site

Quezon, Philippines

Location

Pfizer Investigational Site

Quezon City, Philippines

Location

Pfizer Investigational Site

Singapore, 529889, Singapore

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, 140-757, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Pfizer Investigational Site

Kaohsiung City, Taiwan

Location

Pfizer Investigational Site

Keelung, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Pfizer Investigational Site

Bangkok, 10330, Thailand

Location

Pfizer Investigational Site

Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Bangkok, 10700, Thailand

Location

Pfizer Investigational Site

Bangkok, Thailand

Location

Pfizer Investigational Site

Location

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

valdecoxib; Diclofenac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: March 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: October 8, 2008

Record last verified: 2008-10

Locations

MY (3); TW (3); TH (4); SG (1); AU (1); KR (4); PH (3); NZ (3); HK (2)