Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
NCT ID: NCT04671082
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1004 participants
INTERVENTIONAL
2020-12-15
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tolperisone 50 mg
Tolperisone 50 mg
Tolperisone Hydrochloride
TID
Tolpersione 100 mg
Tolperisone 100 mg
Tolperisone Hydrochloride
TID
Tolperisone 200 mg
Tolperisone 200 mg
Tolperisone Hydrochloride
TID
Placebo
Placebo
Placebo
TID
Interventions
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Tolperisone Hydrochloride
TID
Placebo
TID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
64 Years
ALL
No
Sponsors
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Neurana Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Institute of Arizona, LLC
Surprise, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Alliance Research Institute
Canoga Park, California, United States
Long Beach Clinical Trials Services, Inc
Long Beach, California, United States
Northern California Research
Sacramento, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
LCC Medical Research Institute, LLC
Miami, Florida, United States
Savin Medical Group
Miami Lakes, Florida, United States
Accel Research Sites
Orange City, Florida, United States
Combined Research Orlando
Orlando, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Georgia Clinical Research LLC
Lawrenceville, Georgia, United States
IMA Clinical Research, PC
Chicago, Illinois, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States
Investigators Research Group
Brownsburg, Indiana, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
DelRicht Research
New Orleans, Louisiana, United States
DelRicht Research
Prairieville, Louisiana, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Onyx Clinical Research
Rochester Hills, Michigan, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, United States
IMA Clinical Research
St Louis, Missouri, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, United States
Skyline Medical Center, PC
Elkhorn, Nebraska, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Drug Trials America
Hartsdale, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
Advanced Research Solutions, LLC
Staten Island, New York, United States
Upstate ClinicalResearch Associates LLC
Williamsville, New York, United States
Carolina Research Center, Inc.
Shelby, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Onyx Clinical Research
Youngstown, Ohio, United States
Today Clinical Research
Oklahoma City, Oklahoma, United States
DelRicht Research
Tulsa, Oklahoma, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
PCPMG Clinical Research Unit, LLC
Anderson, South Carolina, United States
New Phase Research & Development, LLC
Knoxville, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
Premier Family Physicians
Austin, Texas, United States
ClinRx Research Joseph INC
Carrollton, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
R & H Clinical Research
Katy, Texas, United States
Village Health Partners
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Countries
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References
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Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.
Other Identifiers
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RESUME-1
Identifier Type: OTHER
Identifier Source: secondary_id
CLN-301
Identifier Type: -
Identifier Source: org_study_id
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