Low Back PainPhase 3NCT01979510

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)

A Phase 3 study testing MK-0663B, DOLOCAM PLUS® and Acetaminophen 500 mg in people with Low Back Pain, run by Merck Sharp & Dohme LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Low Back Pain
What is being tested?: MK-0663B, DOLOCAM PLUS® and Acetaminophen 500 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Nov 2013to May 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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

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
Being tested: MK-0663B, DOLOCAM PLUS®, Acetaminophen 500 mg
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0663BDrug
MK-0663B once daily for 8 days.
DOLOCAM PLUS®Drug
DOLOCAM PLUS® once daily for 8 days.
Acetaminophen 500 mgDrug
Acetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.

Study groups in NCT01979510
Study group	Role	What they receive
MK-0663B	Experimental	MK-0663B (etoricoxib 90 mg immediate release [IR]/tizanidine 6 mg modified release [MR]) capsules once daily for 8 days. Receives: Drug: MK-0663B; Drug: Acetaminophen 500 mg
DOLOCAM PLUS®	Experimental	DOLOCAM PLUS® (meloxicam 7.5mg/methocarbamol 215mg) capsules once daily for 8 days. Receives: Drug: DOLOCAM PLUS®; Drug: Acetaminophen 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing an Adverse Event (AE)
Measured: Up to Day 23
Number of Participants Discontinuing Study Treatment Due to an AE
Measured: Up to Day 8

Secondary outcomes (7)

Mean Change From Baseline in the Participant Low Back Pain Questionnaire Score
Measured: Baseline and Day 9
Mean Change From Baseline in the Participant Roland Morris Disability Questionnaire
Measured: Baseline and Day 9
Number of Participants With ≥30% Improvement From Baseline in the Roland Morris Disability
Measured: Baseline and Day 9
Mean Change From Baseline in the Participant Global Assessment of Response to Therapy.
Measured: Baseline and Day 9
Mean Change From Baseline in the Investigator Global Assessment of Response to Therapy
Measured: Baseline and Day 9
Average Amount of Rescue Medication Required by Participant During Study Treatment
Measured: Up to Day 8
Proportion of Participants Using Rescue Medication During Study Treatment
Measured: Up to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013May 2014

First posted8 Nov 2013 (estimated)
Study startNov 2013
Primary completionMay 2014 (estimated)
Study completionMay 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979510
Sponsor's protocol ID: 0663B-164
Status last verified: Apr 2015
First submitted: 4 Nov 2013
Last updated: 27 Apr 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01979510
Acronym / sponsor ID: 0663B-164
Conditions: Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: May 2014 (estimated)
Study completion: May 2014 (estimated)
First posted: 8 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MK-0663B	Experimental	Drug: MK-0663B, Drug: Acetaminophen 500 mgMK-0663B (etoricoxib 90 mg immediate release [IR]/tizanidine 6 mg modified release [MR]) capsules once daily for 8 days.
DOLOCAM PLUS®	Experimental	Drug: DOLOCAM PLUS®, Drug: Acetaminophen 500 mgDOLOCAM PLUS® (meloxicam 7.5mg/methocarbamol 215mg) capsules once daily for 8 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (25 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-0663BMK-0663B once daily for 8 days.	Drug	MK-0663B
DOLOCAM PLUS®DOLOCAM PLUS® once daily for 8 days.	Drug	DOLOCAM PLUS®
Acetaminophen 500 mgAcetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.	Drug	DOLOCAM PLUS®, MK-0663B

Primary outcome

Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to Day 23
Number of Participants Discontinuing Study Treatment Due to an AE
Time frame: Up to Day 8

7 secondary outcomes

Mean Change From Baseline in the Participant Low Back Pain Questionnaire Score
Time frame: Baseline and Day 9
Mean Change From Baseline in the Participant Roland Morris Disability Questionnaire
Time frame: Baseline and Day 9
Number of Participants With ≥30% Improvement From Baseline in the Roland Morris Disability
Time frame: Baseline and Day 9
Mean Change From Baseline in the Participant Global Assessment of Response to Therapy.
Time frame: Baseline and Day 9
Mean Change From Baseline in the Investigator Global Assessment of Response to Therapy
Time frame: Baseline and Day 9
Average Amount of Rescue Medication Required by Participant During Study Treatment
Time frame: Up to Day 8
Proportion of Participants Using Rescue Medication During Study Treatment
Time frame: Up to Day 8

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.

Related trials for Low Back Pain

Not yet recruiting
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-0663B, DOLOCAM PLUS® and Acetaminophen 500 mg in people with Low Back Pain, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing an Adverse Event (AE) (time frame: Up to Day 23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.