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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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00650039
Collaborator
(none)
488
Enrollment
81
Locations
3
Arms
11.1
Duration (Months)
6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
488 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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
Study Start Date :
Mar 1, 2004
Actual Study Completion Date :
Feb 1, 2005

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Summed Pain Intensity (categorical) through 24 hours (SPI 24) [Day 2 and Day 3]

  2. Patient's Global Evaluation of Study Medication (PGESM) [Day 2 and Day 3]

Secondary Outcome Measures

  1. Average Pain Intensity (derived from the mBPI-sf) on each study day [Days 2 to 5]

  2. Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day [Days 2 to 5]

  3. Symptom Distress Scale Questionnaire [Days 2 to 5]

  4. Patient Satisfaction Questionnaire for each study day [Days 2 to 5]

  5. Time-specific pain intensity (PI) (categorical) on each study day [Days 2 to 5]

  6. SPI 24 (Visual Analog Scale [VAS]) on each study day [Days 2 to 5]

  7. Time-specific PI (VAS) on each study day [Days 2 to 5]

  8. Patient's Global Evaluation of Study Medication [Day 4 and Day 5]

  9. Time to first dose of rescue medication (supplemental analgesia) on each study day [Days 2 to 5]

  10. Percent of subjects who took rescue medication (supplemental analgesia) on each study day [Days 2 to 5]

  11. Amount of rescue medication (supplemental analgesia) taken on each study day [Days 2 to 5]

  12. Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day [Days 2 to 5]

  13. Time between doses of study medication on each study day [Days 2 to 5]

  14. Post-Discharge Recovery Experience for each study day [Days 2 to 5]

  15. SPI 24 (categorical) [Day 4 and Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35205
2 Pfizer Investigational Site Birmingham Alabama United States 36205
3 Pfizer Investigational Site Northport Alabama United States 35476
4 Pfizer Investigational Site Glendale Arizona United States 85310
5 Pfizer Investigational Site Pheonix Arizona United States 85006
6 Pfizer Investigational Site Pheonix Arizona United States 85008
7 Pfizer Investigational Site Pheonix Arizona United States 85016
8 Pfizer Investigational Site Phoenix Arizona United States 85016
9 Pfizer Investigational Site Phoenix Arizona United States 85032
10 Pfizer Investigational Site Tempe Arizona United States 85281
11 Pfizer Investigational Site Glendale California United States 91206
12 Pfizer Investigational Site Laguna Hills California United States 92653
13 Pfizer Investigational Site Laguna Woods California United States 92653
14 Pfizer Investigational Site Los Angeles California United States 90045
15 Pfizer Investigational Site Avon Connecticut United States 06001
16 Pfizer Investigational Site Cromwell Connecticut United States 06416
17 Pfizer Investigational Site Enfield Connecticut United States 06082
18 Pfizer Investigational Site Farmington Connecticut United States 06030
19 Pfizer Investigational Site Farmington Connecticut United States 06032
20 Pfizer Investigational Site Glastonbury Connecticut United States 06033
21 Pfizer Investigational Site Hartford Connecticut United States 06102
22 Pfizer Investigational Site Hartford Connecticut United States 06106
23 Pfizer Investigational Site Rocky Hill Connecticut United States 06067
24 Pfizer Investigational Site Windsor Connecticut United States 06095
25 Pfizer Investigational Site Hollywood Florida United States 33021
26 Pfizer Investigational Site Jacksonville Florida United States 32216
27 Pfizer Investigational Site Jacksonville Florida United States 32250
28 Pfizer Investigational Site Plantation Florida United States 33324
29 Pfizer Investigational Site St. Augustine Florida United States 32086
30 Pfizer Investigational Site St. Petersburg Florida United States 33703
31 Pfizer Investigational Site Weston Florida United States 33326
32 Pfizer Investigational Site Atlanta Georgia United States 30327
33 Pfizer Investigational Site Morrow Georgia United States 30260
34 Pfizer Investigational Site Stockbridge Georgia United States 30281
35 Pfizer Investigational Site Chicago Illinois United States 60304
36 Pfizer Investigational Site Chicago Illinois United States 60612
37 Pfizer Investigational Site Oak Park Illinois United States 60304
38 Pfizer Investigational Site Cedar Rapids Iowa United States 52401
39 Pfizer Investigational Site Lexington Kentucky United States 40504
40 Pfizer Investigational Site Lexington Kentucky United States 40509
41 Pfizer Investigational Site Baltimore Maryland United States 21218
42 Pfizer Investigational Site Timonium Maryland United States 21093
43 Pfizer Investigational Site Royal Oak Michigan United States 48073
44 Pfizer Investigational Site Troy Michigan United States 48085
45 Pfizer Investigational Site Springfield Missouri United States 65804
46 Pfizer Investigational Site Springfield Missouri United States 65807
47 Pfizer Investigational Site Las Vegas Nevada United States 89106
48 Pfizer Investigational Site Las Vegas Nevada United States 89117
49 Pfizer Investigational Site Las Vegas Nevada United States 89121
50 Pfizer Investigational Site Las Vegas Nevada United States 89144
51 Pfizer Investigational Site Bend Oregon United States 97701
52 Pfizer Investigational Site Anderson South Carolina United States 29621
53 Pfizer Investigational Site Cola South Carolina United States 29212
54 Pfizer Investigational Site Columbia South Carolina United States 29202
55 Pfizer Investigational Site Columbia South Carolina United States 29204
56 Pfizer Investigational Site Orangeburg South Carolina United States 29110
57 Pfizer Investigational Site Austin Texas United States 78705
58 Pfizer Investigational Site Dallas Texas United States 75231
59 Pfizer Investigational Site Fort Worth Texas United States 76104
60 Pfizer Investigational Site Fort Worth Texas United States 76107
61 Pfizer Investigational Site San Antonio Texas United States 78127
62 Pfizer Investigational Site San Antonio Texas United States 78209
63 Pfizer Investigational Site San Antonio Texas United States 78217
64 Pfizer Investigational Site San Antonio Texas United States 78229
65 Pfizer Investigational Site San Antonio Texas United States 78240
66 Pfizer Investigational Site San Marcos Texas United States 78666
67 Pfizer Investigational Site Arlington Virginia United States 22205
68 Pfizer Investigational Site Fairfax Virginia United States 22031
69 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 1T2
70 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 3C8
71 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 4V5
72 Pfizer Investigational Site Vancouver British Columbia Canada V6Z 1Y6
73 Pfizer Investigational Site Ajax Ontario Canada L1S 2J4
74 Pfizer Investigational Site Ajax Ontario Canada L1S 2J5
75 Pfizer Investigational Site Ajax Ontario Canada L1S 7K8
76 Pfizer Investigational Site Kingston Ontario Canada K7L 2V7
77 Pfizer Investigational Site Kingston Ontario Canada K7L 5G2
78 Pfizer Investigational Site Scarborough Ontario Canada M1E 4B9
79 Pfizer Investigational Site Toronto Ontario Canada M3M 2C2
80 Pfizer Investigational Site Toronto Ontario Canada M5T 2S8
81 Pfizer Investigational Site Weston Ontario Canada M9N 1N8

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00650039
Other Study ID Numbers:
  • A3471109
First Posted:
Apr 1, 2008
Last Update Posted:
Jun 4, 2008
Last Verified:
Mar 1, 2008
Keywords provided by , ,
Post surgical pain
Anterior Cruciate ligament reconstruction
Arthroscopy
Perioperative pain
Additional relevant MeSH terms:
Pain, Postoperative
Valdecoxib

Study Results

No Results Posted as of Jun 4, 2008