- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979510
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)
April 24, 2015 updated by: Merck Sharp & Dohme LLC
A Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of an Etoricoxib and Tizanidine Fixed Dose Combination in Subjects With Moderate to Severe Acute Low Back Pain
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have acute low back pain;
- Onset of acute low back pain must be <6 weeks prior to screening;
- Have acute low back pain corresponding to a rating of ≥ 4 on a 0-10 point Low Back Pain Questionnaire and ≥ 7 on the Roland Morris Questionnaire;
- For women of childbearing potential, have a negative serum pregnancy test at Visit 1 (Screening Visit) and agree to remain abstinent, use barrier, or non-hormonal implanted contraceptives from study start until 14 days after the last dose of study drug;
- Be willing to limit alcohol use, if any, to 2 drinks or equivalent per day for the duration of the study and follow-up period;
- Be willing to avoid unaccustomed physical activity (e.g., starting a new weight lifting routine) for the duration of the study and follow-up period;
- Be willing to avoid chiropractic care, ultrasound and physical therapy from screening to Day 9;
- Be willing to avoid cold applications and other alternate treatments (e.g. massage, acupuncture etc.) on Day 1 and within 30 minutes prior to scheduled pain assessments on Day 3 and Day 8.
Exclusion Criteria:
- Has low back pain that is related to, or known to be caused by malignancy, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Reiter's syndrome), osteoporosis, ochronosis, vertebral fracture, infection, juvenile scoliosis, congenital malformation, or fibromyalgia. Note: the presence of radiographic degenerative disc disease is not an exclusion;
- Has signs or symptoms consistent with a neurologic, infectious, or fracture-related cause of acute low back pain;
- Has chronic low back pain and is experiencing an acute flare-up of the chronic back pain condition;
- Has radicular or myelopathic pain;
- Has a history of lumbar spine surgery;
- Is involved in an active civil lawsuit or workman's compensation claim pertaining to his/her low back pain;
- Has symptomatic depression that could interfere with the completion of the questionnaires;
- Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of major psychiatric disorder, including any history of psychosis;
- Has a Body Mass Index (BMI) ≥ 40;
- Is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with tizanidine, etoricoxib, methocarbamol, meloxicam, or any non-steroidal anti-inflammatory drug (NSAID);
- Is allergic to acetaminophen/paracetamol;
- Is currently a user (including "recreational use") of any illicit drugs, or has a history (within 5 years) of drug or alcohol abuse;
- Has participated in another investigational drug study within the last 4 weeks;
- Has uncontrolled hypertension;
- Has systolic blood pressure (SBP) < 105 or diastolic blood pressure (DBP) < 65;
- Has a history of orthostatic hypotension;
- Has ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
- Has a positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result;
- Has a history of hepatitis/hepatic disease that has been active within the previous year;
- Has a history of gastric, biliary, or small intestinal surgery or disease that results in clinical malabsorption;
- Has a history of neoplastic disease;
- Has any personal or family history of an inherited or acquired bleeding disorder;
- Is expected to undergo a planned surgical procedure or invasive diagnostic procedure during the course of the study;
- Is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study;
- Has an active peptic ulcer or a history of inflammatory bowel disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MK-0663B
MK-0663B (etoricoxib 90 mg immediate release [IR]/tizanidine 6 mg modified release [MR]) capsules once daily for 8 days.
|
MK-0663B once daily for 8 days.
Acetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.
|
EXPERIMENTAL: DOLOCAM PLUS®
DOLOCAM PLUS® (meloxicam 7.5mg/methocarbamol 215mg) capsules once daily for 8 days.
|
Acetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.
DOLOCAM PLUS® once daily for 8 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to Day 23
|
Up to Day 23
|
Number of Participants Discontinuing Study Treatment Due to an AE
Time Frame: Up to Day 8
|
Up to Day 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Change From Baseline in the Participant Low Back Pain Questionnaire Score
Time Frame: Baseline and Day 9
|
Baseline and Day 9
|
Mean Change From Baseline in the Participant Roland Morris Disability Questionnaire
Time Frame: Baseline and Day 9
|
Baseline and Day 9
|
Number of Participants With ≥30% Improvement From Baseline in the Roland Morris Disability
Time Frame: Baseline and Day 9
|
Baseline and Day 9
|
Mean Change From Baseline in the Participant Global Assessment of Response to Therapy.
Time Frame: Baseline and Day 9
|
Baseline and Day 9
|
Mean Change From Baseline in the Investigator Global Assessment of Response to Therapy
Time Frame: Baseline and Day 9
|
Baseline and Day 9
|
Average Amount of Rescue Medication Required by Participant During Study Treatment
Time Frame: Up to Day 8
|
Up to Day 8
|
Proportion of Participants Using Rescue Medication During Study Treatment
Time Frame: Up to Day 8
|
Up to Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ANTICIPATED)
May 1, 2014
Study Completion (ANTICIPATED)
May 1, 2014
Study Registration Dates
First Submitted
November 4, 2013
First Submitted That Met QC Criteria
November 4, 2013
First Posted (ESTIMATE)
November 8, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 27, 2015
Last Update Submitted That Met QC Criteria
April 24, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Cyclooxygenase 2 Inhibitors
- Acetaminophen
- Etoricoxib
Other Study ID Numbers
- 0663B-164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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