Clinical trial NCT00820027: Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Official title: A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

- Is in generally good health and is scheduled to have a total knee replacement

Exclusion Criteria:

* Is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2) inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs
* Has uncontrolled hypertension
* Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years

Primary outcomes:
measure: Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)
timeFrame: Baseline and Days 1-3
measure: Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)
timeFrame: Days 1-3
measure: Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure
timeFrame: Up to 21 days
measure: Percentage of Participants With at Least One Edema-Related AE
timeFrame: Up to 21 days
measure: Percentage of Participants With at Least One Hypertension-Related AE
timeFrame: Up to 21 days
measure: Percentage of Participants With at Least One Opioid-Related AE
timeFrame: Up to 21 days
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 7 days
Secondary outcomes:
measure: Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
timeFrame: Baseline and Days 1-3
measure: Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
timeFrame: Days 1-3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rawal N, Viscusi E, Peloso PM, Minkowitz HS, Chen L, Shah S, Mehta A, Chitkara DK, Curtis SP, Papanicolaou DA. Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Oct 24;14:300. doi: 10.1186/1471-2474-14-300.