Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650039
First received: March 28, 2008
Last updated: June 3, 2008
Last verified: March 2008
  Purpose

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.


Condition Intervention Phase
Pain
Drug: placebo
Drug: valdecoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Summed Pain Intensity (categorical) through 24 hours (SPI 24) [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication (PGESM) [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Pain Intensity (derived from the mBPI-sf) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Symptom Distress Scale Questionnaire [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Patient Satisfaction Questionnaire for each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time-specific pain intensity (PI) (categorical) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (Visual Analog Scale [VAS]) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time-specific PI (VAS) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
  • Time to first dose of rescue medication (supplemental analgesia) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Percent of subjects who took rescue medication (supplemental analgesia) on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Amount of rescue medication (supplemental analgesia) taken on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time between doses of study medication on each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Post-Discharge Recovery Experience for each study day [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: March 2004
Study Completion Date: February 2005
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
Active Comparator: Arm 2 Drug: valdecoxib
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
Placebo Comparator: Arm 3 Drug: placebo
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Included patients had uncomplicated arthroscopic ACL reconstruction
  • Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
  • Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.

Exclusion Criteria:

  • the patient was admitted to or retained in the surgical center/hospital for >23 hours;
  • the patient underwent 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 used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
  • the patient received oxaprozin or piroxicam within 1 week prior to randomization;
  • the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;
  • the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to the end of anesthesia;
  • patient had a history of clinically significant GI disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650039

  Show 81 Study Locations
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: NCT00650039     History of Changes
Other Study ID Numbers: A3471109
Study First Received: March 28, 2008
Last Updated: June 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Post surgical pain
Anterior Cruciate ligament reconstruction
Arthroscopy
Perioperative pain

Additional relevant MeSH terms:
Analgesics
Valdecoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 25, 2014