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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01979510
Recruitment Status : Withdrawn
First Posted : November 8, 2013
Last Update Posted : April 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: MK-0663B Drug: DOLOCAM PLUS® Drug: Acetaminophen 500 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.
Drug: MK-0663B
MK-0663B 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.

Experimental: DOLOCAM PLUS®
DOLOCAM PLUS® (meloxicam 7.5mg/methocarbamol 215mg) capsules once daily for 8 days.
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.

Primary Outcome Measures :
  1. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 23 ]
  2. Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Day 8 ]

Secondary Outcome Measures :
  1. Mean Change From Baseline in the Participant Low Back Pain Questionnaire Score [ Time Frame: Baseline and Day 9 ]
  2. Mean Change From Baseline in the Participant Roland Morris Disability Questionnaire [ Time Frame: Baseline and Day 9 ]
  3. Number of Participants With ≥30% Improvement From Baseline in the Roland Morris Disability [ Time Frame: Baseline and Day 9 ]
  4. Mean Change From Baseline in the Participant Global Assessment of Response to Therapy. [ Time Frame: Baseline and Day 9 ]
  5. Mean Change From Baseline in the Investigator Global Assessment of Response to Therapy [ Time Frame: Baseline and Day 9 ]
  6. Average Amount of Rescue Medication Required by Participant During Study Treatment [ Time Frame: Up to Day 8 ]
  7. Proportion of Participants Using Rescue Medication During Study Treatment [ Time Frame: Up to Day 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01979510    
Other Study ID Numbers: 0663B-164
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents