A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00788710

Purpose

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.

Condition	Intervention	Phase
Acute Pain	Drug: etoricoxib Drug: Comparator: Placebo	Phase III

MedlinePlus related topics: Hysterectomy

Drug Information available for: Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy

Further study details as provided by Merck:

Primary Outcome Measures:

Overall analgesic effect of etoricoxib as measured by post-operative pain intensity difference over Days 1 through 3 compared to placebo; Tolerability of etoricoxib over 5 days [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction in daily dose of morphine equivalents and pain intensity [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	396
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0663	Drug: etoricoxib Arm 1: MK0663 120 mg tablets once daily, placebo tablets once daily Days 1-5 Arm 2: MK0663 90 mg tablets once daily, placebo tablets once daily Days 1-5 Total treatment is 5 days
2: Experimental MK0663	Drug: etoricoxib Arm 1: MK0663 120 mg tablets once daily, placebo tablets once daily Days 1-5 Arm 2: MK0663 90 mg tablets once daily, placebo tablets once daily Days 1-5 Total treatment is 5 days
3: Placebo Comparator Placebo	Drug: Comparator: Placebo Placebo tablets given once daily on Days 1-5. Total treatment is 5 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

Patient is allergic to the study drug, other COX-2 inhibitors/NSAIDS, ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
Patient has uncontrolled high blood pressure
Patient has a history of drug and/or alcohol abuse within the last 5 years
Patient has taken part in another investigational study within 4 weeks of the start of study
Patient is breast-feeding
Patient has an active ulcer or inflammatory bowel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788710

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Laguna Hills, California, United States, 92653
United States, Texas
Call for Information	Recruiting
Houston, Texas, United States, 77024

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_578, MK0663-097
Study First Received:	November 5, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00788710
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Etoricoxib
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009