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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    1000
  • sponsor
    Neurana Pharmaceuticals, Inc.
Updated on 19 May 2021
opioid
body mass index
acupuncture
back pain
massage
muscle spasm
chiropractic
transcutaneous electrical nerve stimulation

Summary

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.

Details
Condition Back Pain, Muscle Spasm, Pain, Chronic Back Pain, Acute Pain, Post-Surgical Pain, Pain, Acute, Pain (Pediatric), Pain Acute, muscle spasms, spasms, backpain, backache, Back Muscle Spasm, Back Strain, Back Spasm Upper
Treatment Placebo, Tolperisone Hydrochloride
Clinical Study IdentifierNCT04671082
SponsorNeurana Pharmaceuticals, Inc.
Last Modified on19 May 2021

Eligibility

Yes No Not Sure

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/m, 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
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