Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
Primary Purpose
Pain, Postoperative Arthroscopy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966 / Duration of Treatment: 1 Days
Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative Arthroscopy
Eligibility Criteria
Inclusion Criteria:
- Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
- Patients must experience moderate to severe pain following surgery
- Patient must be in general good health as judged by the primary investigator
Exclusion Criteria:
- Osteoarthritis; rheumatoid arthritis
- Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
- Asthma associated with nasal polyps
- Any arthroscopic knee surgery in the past 6 months
Sites / Locations
Outcomes
Primary Outcome Measures
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
Secondary Outcome Measures
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
Full Information
NCT ID
NCT00390260
First Posted
October 18, 2006
Last Updated
January 31, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00390260
Brief Title
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
Official Title
Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
420 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966 / Duration of Treatment: 1 Days
Intervention Type
Drug
Intervention Name(s)
Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
Primary Outcome Measure Information:
Title
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
Patients must experience moderate to severe pain following surgery
Patient must be in general good health as judged by the primary investigator
Exclusion Criteria:
Osteoarthritis; rheumatoid arthritis
Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
Asthma associated with nasal polyps
Any arthroscopic knee surgery in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17207303
Citation
Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
We'll reach out to this number within 24 hrs