- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01968005
Etodolac-Lidocaine Patch in the Treatment of Acute Low Back Pain
January 14, 2018 updated by: MEDRx USA, Inc.
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the Treatment of Acute Low Back Pain
The purpose of this study is to evaluate efficacy, tolerability and safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Carlsbad, California, United States, 92008
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Florida
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Miami, Florida, United States, 33155
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New York
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New York, New York, United States, 10022
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Ohio
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Zanesville, Ohio, United States, 43701
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Texas
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Dallas, Texas, United States, 75234
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El Paso, Texas, United States, 79902
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San Antonio, Texas, United States, 78207
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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
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control.
- Subject has an exacerbation of acute low back pain with the onset of the current episode ≥3 and ≤7 days preceding the screening visit. The acute back pain must be muscular in origin.
- Subject has a Current Pain Intensity
Exclusion Criteria:
- Subjects with LBP potentially associated with a specific spinal cause (e.g. known high-grade spondylolisthesis [Grade 3 or 4], tumour, infection, vertebral compression fracture [history ≤1 year], Paget's disease, osteoporosis, spinal stenosis).
- Any past low-back surgery, or scheduled low back surgery during the trial, or any other scheduled surgery or painful procedure during the course of the trial that, in the opinion of the investigator, may affect efficacy or safety assessments.
- Invasive procedures (e.g. epidural injections, spinal cord stimulation therapy) within the past six months aimed to reduce LBP.
- Clinically relevant history of hypersensitivity, allergy or contraindications to any of the IPs' excipients, or to aspirin-like drugs
- Presence of conditions other than LBP that in the investigator's opinion could confound the assessment or self-evaluation of pain, such as but not limited to anatomical deformities, significant skin conditions such as infections (abscesses or ulcers), unilateral or bilateral lower limb pain independent from the indication LBP, painful venous insufficiency, painful post thrombotic syndrome, painful osteoarthritis of the knee, distal lower limb inflammation, or diffuse widespread pain such as fibromyalgia.
- Subject has received passive physical therapy treatments (e.g. deep heat or ultrasound) or used iontophoresis for the pain within the past 12 hours; or requires continued use of an immobilization device for treatment of the current episode of low back pain. Subject on any therapeutic exercise regimen should stay on the same regimen for the duration of the study.
- Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less than 5 half-lives before the baseline assessments; acetaminophen or ibuprofen is permitted prior to baseline as long as it is not within six hours of the baseline assessment. Aspirin (81-325 mg daily) taken prophylactically for cardiovascular reasons is permitted.
- Subject has used any form of opioid within 24 hours of study entry or use of opioids for five or more consecutive days within the 30 days preceding enrolment.
- Subject has received systemic corticosteroids in the 30 days preceding the screening visit (e.g. oral, or parenteral administration) or local injections such as intra-articular, peri-tendinous (topical acceptable, unless applied to the target effected area and inhaled or intranasal steroids acceptable, e.g. Flonase®)
- Subject has recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days); if using any of these, subject must be on a stable dose and regimen for 30 days prior to study enrolment.
- Subject has used TNF-alpha blockers of any type or Class 1 anti-arrhythmic drugs within the past 60 days.
- Subject has a history or physical assessment finding of clinically significant GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart or other vital organ disease as determined by the study investigator/physician.
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Therapy with placebo
|
Other Names:
|
Experimental: Etoreat®(Etodolac-Lidocaine Topical Patch)
Therapy with experimental drug
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SPID (Summed pain intensity difference) from baseline over the pain assessments from Day 1 to Day 8
Time Frame: 8 days
|
8 days
|
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 (Actual)
May 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
October 18, 2013
First Submitted That Met QC Criteria
October 18, 2013
First Posted (Estimate)
October 23, 2013
Study Record Updates
Last Update Posted (Actual)
January 17, 2018
Last Update Submitted That Met QC Criteria
January 14, 2018
Last Verified
January 1, 2018
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
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cyclooxygenase 2 Inhibitors
- Lidocaine
- Etodolac
Other Study ID Numbers
- MRX-7EAT-1009
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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