Acute Pain Clinical Trial
— RESUME-1Official title:
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
| Verified date | March 2022 |
| Source | Neurana Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1004 |
| Est. completion date | March 21, 2022 |
| Est. primary completion date | December 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico |
| United States | PCPMG Clinical Research Unit, LLC | Anderson | South Carolina |
| United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Lynn Institute of Denver | Aurora | Colorado |
| United States | Central Texas Clinical Research | Austin | Texas |
| United States | Premier Family Physicians | Austin | Texas |
| United States | Pioneer Clinical Research, LLC | Bellevue | Nebraska |
| United States | Integrative Clinical Trials, LLC | Brooklyn | New York |
| United States | Investigators Research Group | Brownsburg | Indiana |
| United States | Alliance Research Institute | Canoga Park | California |
| United States | ClinRx Research Joseph INC | Carrollton | Texas |
| United States | IMA Clinical Research, PC | Chicago | Illinois |
| United States | Hometown Urgent Care and Research | Cincinnati | Ohio |
| United States | Hometown Urgent Care and Research | Columbus | Ohio |
| United States | Spectrum Medical, Inc. | Danville | Virginia |
| United States | Hometown Urgent Care and Research | Dayton | Ohio |
| United States | iResearch Atlanta | Decatur | Georgia |
| United States | Skyline Medical Center, PC | Elkhorn | Nebraska |
| United States | Evanston Premier Healthcare Research LLC | Evanston | Illinois |
| United States | Drug Trials America | Hartsdale | New York |
| United States | Centex Studies, Inc. | Houston | Texas |
| United States | Centex Studies, Inc. | Houston | Texas |
| United States | R & H Clinical Research | Katy | Texas |
| United States | New Phase Research & Development, LLC | Knoxville | Tennessee |
| United States | Multi-Specialty Research Associates, Inc. | Lake City | Florida |
| United States | Jubilee Clinical Research, Inc. | Las Vegas | Nevada |
| United States | Georgia Clinical Research LLC | Lawrenceville | Georgia |
| United States | Applied Research Center of Arkansas | Little Rock | Arkansas |
| United States | Long Beach Clinical Trials Services, Inc | Long Beach | California |
| United States | LCC Medical Research Institute, LLC | Miami | Florida |
| United States | Savin Medical Group | Miami Lakes | Florida |
| United States | DelRicht Research | New Orleans | Louisiana |
| United States | Manhattan Behavioral Medicine PLLC | New York | New York |
| United States | Health Research of Hampton Roads, Inc. | Newport News | Virginia |
| United States | Today Clinical Research | Oklahoma City | Oklahoma |
| United States | Accel Research Sites | Orange City | Florida |
| United States | Combined Research Orlando | Orlando | Florida |
| United States | Research Integrity, LLC | Owensboro | Kentucky |
| United States | Village Health Partners | Plano | Texas |
| United States | DelRicht Research | Prairieville | Louisiana |
| United States | Quinn Healthcare/SKYCRNG | Ridgeland | Mississippi |
| United States | Onyx Clinical Research | Rochester Hills | Michigan |
| United States | Northern California Research | Sacramento | California |
| United States | IMA Clinical Research | Saint Louis | Missouri |
| United States | Sun Research Institute | San Antonio | Texas |
| United States | Carolina Research Center, Inc. | Shelby | North Carolina |
| United States | Frontier Clinical Research, LLC | Smithfield | Pennsylvania |
| United States | Advanced Research Solutions, LLC | Staten Island | New York |
| United States | Clinical Research Institute of Arizona, LLC | Surprise | Arizona |
| United States | Collaborative Neuroscience Research, LLC | Torrance | California |
| United States | DelRicht Research | Tulsa | Oklahoma |
| United States | Emerson Clinical Research Institute | Washington | District of Columbia |
| United States | Professional Research Network of Kansas, LLC | Wichita | Kansas |
| United States | Upstate ClinicalResearch Associates LLC | Williamsville | New York |
| United States | Progressive Medicine of the Triad, LLC | Winston-Salem | North Carolina |
| United States | Onyx Clinical Research | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Neurana Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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