Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.

Official Title
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A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

Conditions
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Back Muscle Spasm, Back Pain, Back Strain, Back Spasm Upper, Muscle Spasm, Acute Pain

Intervention / Treatment
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* Drug: Tolperisone Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain. Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation [TENS], or physiotherapy. Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination. Body mass index range between 18 and 35 kg/m², inclusive. Exclusion Criteria: Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not. Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or pinched nerve) or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities. Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken. History of any neck, back, or pelvic surgery. History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain. Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolperisone 50 mg<br>Tolperisone 50 mg | Drug: Tolperisone Hydrochloride<br>* TID<br>* Other names: Tolperisone;|
| Experimental: Tolpersione 100 mg<br>Tolperisone 100 mg | Drug: Tolperisone Hydrochloride<br>* TID<br>* Other names: Tolperisone;|
| Experimental: Tolperisone 200 mg<br>Tolperisone 200 mg | Drug: Tolperisone Hydrochloride<br>* TID<br>* Other names: Tolperisone;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain right now due to acute back spasm. | Day 1 to Day 14 |