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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650598
First received: March 31, 2008
Last updated: October 6, 2008
Last verified: October 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pain, Postoperative |
Drug: valdecoxib Drug: diclofenac |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physical examination [ Time Frame: Screening and Day 6 ] [ Designated as safety issue: Yes ]
- Global Evaluation of Study Medication [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]
- Consumption of Rescue Medication [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]
- Modified Brief Pain Inventory - short form [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Days 1-6 ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: Screening, Day 1, and Day 6 ] [ Designated as safety issue: Yes ]
- Effect on Pain Medication Questionnaire and Health Resource Utilization [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]
| Enrollment: | 328 |
| Study Start Date: | March 2004 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650598
Locations
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, SA 5000 | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Hong Kong, Hong Kong | |
| Pfizer Investigational Site | |
| Shatin, New Territories, Hong Kong | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 140-757 | |
| Pfizer Investigational Site | |
| Unknown, Korea, Republic of | |
| Malaysia | |
| Pfizer Investigational Site | |
| Cheras, Kuala Lumpur, Malaysia, 56000 | |
| Pfizer Investigational Site | |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100 | |
| Pfizer Investigational Site | |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586 | |
| New Zealand | |
| Pfizer Investigational Site | |
| Auckland, New Zealand | |
| Pfizer Investigational Site | |
| Christchurch, New Zealand | |
| Pfizer Investigational Site | |
| Wellington, New Zealand | |
| Philippines | |
| Pfizer Investigational Site | |
| Manila, Philippines | |
| Pfizer Investigational Site | |
| Quezon, Philippines | |
| Pfizer Investigational Site | |
| Quezon City, Philippines | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 529889 | |
| Pfizer Investigational Site | |
| Unknown, Singapore, 169608 | |
| Pfizer Investigational Site | |
| Unknown, Singapore, 308433 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Kaohsiung, Taiwan | |
| Pfizer Investigational Site | |
| Keelung, Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan | |
| Thailand | |
| Pfizer Investigational Site | |
| Bangkok, Thailand, 10700 | |
| Pfizer Investigational Site | |
| Bangkok, Thailand, 10400 | |
| Pfizer Investigational Site | |
| Bangkok, Thailand | |
| Pfizer Investigational Site | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00650598 History of Changes |
| Other Study ID Numbers: | A3471039 |
| Study First Received: | March 31, 2008 |
| Last Updated: | October 6, 2008 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by Pfizer:
|
anterior cruciate ligament, arthroscopy, knee, post-surgical pain |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Analgesics Diclofenac Valdecoxib Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013