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Safety and Efficacy Study of an Etoricoxib and Tizanidine Fixed Dose Combination in Participants With Moderate to Severe Acute Low Back Pain (MK-0663B-164)

NCT01979510 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-27

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of MK-0663B (etoricoxib/tizanidine) among participants with moderate-to-severe acute low back pain.

Conditions

  • Low Back Pain

Interventions

DRUG

MK-0663B

MK-0663B once daily for 8 days.

DRUG

DOLOCAM PLUS®

DOLOCAM PLUS® once daily for 8 days.

DRUG

Acetaminophen 500 mg

Acetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01979510 on ClinicalTrials.gov