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NCT01979510 | Withdrawn Phase 3 DMC

• 1 other identifier: 0663B-164
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing an Adverse Event (AE)

  Up to Day 23

• Number of Participants Discontinuing Study Treatment Due to an AE

  Up to Day 8

Secondary Outcomes (7)

• Mean Change From Baseline in the Participant Low Back Pain Questionnaire Score

  Baseline and Day 9

• Mean Change From Baseline in the Participant Roland Morris Disability Questionnaire

  Baseline and Day 9

• Number of Participants With ≥30% Improvement From Baseline in the Roland Morris Disability

  Baseline and Day 9

• Mean Change From Baseline in the Participant Global Assessment of Response to Therapy.

  Baseline and Day 9

• Mean Change From Baseline in the Investigator Global Assessment of Response to Therapy

  Baseline and Day 9

Study Arms (2)

MK-0663B

EXPERIMENTAL

MK-0663B (etoricoxib 90 mg immediate release \[IR\]/tizanidine 6 mg modified release \[MR\]) capsules once daily for 8 days.

Drug: MK-0663B; Drug: Acetaminophen 500 mg

DOLOCAM PLUS®

EXPERIMENTAL

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

Drug: DOLOCAM PLUS®; Drug: Acetaminophen 500 mg

Interventions

MK-0663B DRUG

MK-0663B once daily for 8 days.

MK-0663B

DOLOCAM PLUS® DRUG

DOLOCAM PLUS® once daily for 8 days.

DOLOCAM PLUS®

Acetaminophen 500 mg DRUG

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

DOLOCAM PLUS®; MK-0663B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04