Overview

Etodolac-Lidocaine Patch in the Treatment of Acute Low Back Pain

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MEDRx USA, Inc.
Treatments:
Etodolac
Lidocaine
Criteria
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.