Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390260

Enrollment

420

Registered

2006-10-19

Start date

2002-02-28

Completion date

2003-02-28

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative Arthroscopy

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.

Interventions

DRUGMK0966 / Duration of Treatment: 1 Days

DRUGComparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days

DRUGComparator: placebo (unspecified) / Duration of Treatment: 1 Days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total Pain Relief over 6 hours following a single oral dose compared to placebo.	6 hours

Secondary

Measure	Time frame
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.	6 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026