Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00393354

First received: October 26, 2006

Last updated: May 20, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2006

Last Updated Date

May 20, 2013

Start Date ^ICMJE

April 2000

Primary Completion Date

November 2000 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00393354 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)(COMPLETED)

Official Title ^ICMJE

A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain

Brief Summary

Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Recurrent Low Back Pain

Intervention ^ICMJE

Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

Not Provided

Primary Completion Date

November 2000 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Low back pain for previous 3 months and majority of days in last month
Regular use of acetaminophen or NSAID to treat low back pain in past month
Judged to be in otherwise good health

Exclusion Criteria:

Low back pain that is due to secondary causes
Radicular/myelopathic pain
Surgery for low back pain within the past 6 months
Active lawsuit or claim pertaining to their low back pain
Disease that may confound the results of the study or pose risk to the patients
Corticosteroid use in past month
Previous participation in MK0663 study

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00393354

Other Study ID Numbers ^ICMJE

2006_548, MK0663-041

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top