Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
415 participants
INTERVENTIONAL
2019-02-01
2019-07-12
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
TID (150 mg/day)
Tolperisone
TID
Tolperisone 100 mg
TID (300 mg/day)
Tolperisone
TID
Tolperisone 150 mg
TID (450 mg/day)
Tolperisone
TID
Tolperisone 200 mg
TID (600 mg/day)
Tolperisone
TID
Placebo
TID
Placebo
Placebo
Interventions
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Tolperisone
TID
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
* Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
* Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
* Pain localized below the neck and above the inferior gluteal folds.
* Body mass index ranging between 18 and 35 kg/m².
Exclusion Criteria
* Chronic pain for the previous 3 months or longer, on more days than not.
* Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
* Concomitant severe pain in a region other than the back.
* Spinal surgery within 1 year of study entry.
* Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
* Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation \[TENS\], physiotherapy).
* Subjects who test positive for alcohol by breathalyzer test.
* Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
18 Years
65 Years
ALL
No
Sponsors
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Neurana Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Tennessee Valley Pain Consultants
Huntsville, Alabama, United States
Fiel Family and Sports Medicine
Tempe, Arizona, United States
Center of Applied Research
Little Rock, Arkansas, United States
Research Center of Fresno
Fresno, California, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, United States
Northern California Research
Sacramento, California, United States
Pacific Research Network, LLC
San Diego, California, United States
San Diego Sports Medicine
San Diego, California, United States
CITrials
Santa Ana, California, United States
Riverside Clinical Research
Edgewater, Florida, United States
Empirical Research Group
Gainesville, Florida, United States
LLC Medical Research
Miami, Florida, United States
Savin Medical Group
Miami Lakes, Florida, United States
Avail Clinical Research
Orange City, Florida, United States
Private Practice
Plantation, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Georgia Institute for Clinical Research
Marietta, Georgia, United States
Georgia Clinical Research
Snellville, Georgia, United States
MediSphere Medical Research Center
Evansville, Indiana, United States
Otrimed Clinical Research
Edgewood, Kentucky, United States
Centex Studies, Inc.
Lake Charles, Louisiana, United States
Center for Rheumatology and Bone
Wheaton, Maryland, United States
Michigan Head Pain and Neurological
Ann Arbor, Michigan, United States
Sundance Clinical Research
St Louis, Missouri, United States
Jubilee Clinical Research
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Clinical Trials of America
Winston-Salem, North Carolina, United States
Sterling Research Group- Springdale
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Center for Providence Health Partners
Dayton, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Williamette Valley Clinical Studies
Eugene, Oregon, United States
Frontier Clinical Research, Inc.
Smithfield, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Health Concepts
Rapid City, South Dakota, United States
Inquest Clinical Research
Baytown, Texas, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
HD Research Corp
Houston, Texas, United States
Centex Studies, Inc.
McAllen, Texas, United States
ClinRX Research Joseph, Inc.
Plano, Texas, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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201
Identifier Type: -
Identifier Source: org_study_id
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