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
NCT00650039
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Ottawa, Ontario
- Funabashi, Chiba
- Ichikawa, Chiba
- Matsudo, Chiba
- Sagamihara, Kanagawa
- Ageo, Saitama
- Saitama-shi, Saitama
- Edogawaku, Tokyo
- Kotoku, Tokyo
- Nerimaku, Tokyo
- Toshimaku, Tokyo
- Kofu, Yamanashi
- Port Macquarie, New South Wales
- Randwick, New South Wales
- Westmead, New South Wales
- Coopers Plain, Queensland
- Townsville, Queensland
- Heidelberg, Victoria
- Prahran, Victoria
- Perth, Western Australia
- Warrawong, New South Wales
- Westmead, New South Wales
- Kippa Ring, Queensland
- Maroochydore, Queensland
- Bedford Park, South Australia
- Perth, Western Australia
- Woodville,
- Kelowna, British Columbia
- Halifax, Nova Scotia
- Toronto, Ontario
- Sherbrooke, Quebec
- Ste-foy, Quebec
- Brno,
- Ceske Budejovice,
- CZ-Praha 8,
- Plzen,
- Praha 5,
- Arnhem,
- Breda,
- Kampen,
- Roosendaal,
- Rotterdam,
- Stadskanaal,
- Barcelona,
- Granada,
- Madrid,
- Malaga,
- Sevilla,
- Portsmouth, Hants
- Northampton, Northants
- London,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Pain | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 488 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00650039 | |||
Other Study ID Numbers ICMJE | A3471109 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |