Low Back PainPhase 3NCT01968005
Etodolac-Lidocaine Patch in the Treatment of Acute Low Back Pain
A Phase 3 study testing Etoreat®(Etodolac-Lidocaine Topical Patch) in people with Low Back Pain, run by MEDRx USA, Inc. at 7 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Etoreat®(Etodolac-Lidocaine Topical Patch)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2013to Nov 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Carlsbad, California, 92008
Study site
Dallas, Texas, 75234
Study site
El Paso, Texas, 79902
Study site
Miami, Florida, 33155
Study site
New York, New York, 10022
Study site
San Antonio, Texas, 78207
Study site
Zanesville, Ohio, 43701
About this study
Official title: 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).
- Conditions
- Low Back Pain
- Being tested
- Etoreat®(Etodolac-Lidocaine Topical Patch), Placebo
- 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.
Etoreat®(Etodolac-Lidocaine Topical Patch)Drug
Also called Once daily application of Two patches for 14 days
PlaceboDrug
Also called Once daily application of Two patches for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Therapy with placebo Receives: Drug: Placebo |
| Etoreat®(Etodolac-Lidocaine Topical Patch) | Experimental | Therapy with experimental drug Receives: Drug: Etoreat®(Etodolac-Lidocaine Topical Patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID (Summed pain intensity difference) from baseline over the pain assessments from Day 1 to Day 8
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionNov 2014
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.
- 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDRx USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968005
- Sponsor's protocol ID
- MRX-7EAT-1009
- Status last verified
- Jan 2018
- First submitted
- 18 Oct 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01968005
- Acronym / sponsor ID
- MRX-7EAT-1009
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- MEDRx USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Oct 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTherapy with placebo |
| Etoreat®(Etodolac-Lidocaine Topical Patch) | Experimental | Drug: Etoreat®(Etodolac-Lidocaine Topical Patch)Therapy with experimental drug |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Etoreat®(Etodolac-Lidocaine Topical Patch)Also: Once daily application of Two patches for 14 days | Drug | Etoreat®(Etodolac-Lidocaine Topical Patch) |
| PlaceboAlso: Once daily application of Two patches for 14 days | Drug | Placebo |
Primary outcome
SPID (Summed pain intensity difference) from baseline over the pain assessments from Day 1 to Day 8
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoreat®(Etodolac-Lidocaine Topical Patch) in people with Low Back Pain, run by MEDRx USA, Inc. at 7 sites in United States.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SPID (Summed pain intensity difference) from baseline over the pain assessments from Day 1 to Day 8 (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2018.