Acute, non-specific low back pain MedDRA version: 21.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Miderizone
Product Name: Miderizone
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOLPERISONE HYDROCHLORIDE
CAS Number: 3644-61-9
Concentration unit: mg milligram(s)
Concent
Sponsors
MEDITOP Gyógyszeripari Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written and signed informed consent form, obtained prior to starting any study related protocol-specific procedures. 2.Age between 18 and 55 years (inclusive both males and females). 3.18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg) 4.Non-specific low back pain (as primary painful condition) fulfilling each of the following criteria: •Localized below the costal margin and above the inferior gluteal folds •Time of onset is not more than 3 days prior to baseline visit •Pain intensity for pain on movement without medication on a 10 point VAS scale is at least 7 at the baseline visit •Presence of muscle spasm by palpation as assessed by the investigator during baseline visit. (Muscle spasticity of the lumbar region is assessed as 2 or 3 on a scale of 0-3.) 5.For women of childbearing potential, agreement to use highly effective form of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 355 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Significant surgery in the low back region in the medical history (such as but not limited to malignancy, discectomy, spinal fusion). 2.Chronic low back pain in the past or ongoing for the last 3 months. 3.Previous low-back pain episode within 3 months of baseline. 4.Explicit radicular signs, ie. muscle weakness, loss of reflexes and paraesthesia according to dermatome. If the patient reports mild paraesthesia (not connected to a dermatome) and/or mild radicular pain but none of the symptoms listed are present, the patient can be enrolled in the study. 5.Known or suspected pathological conditions resulting pain in the low back/abdominal region (such as abscess, tumor, spinal fracture, Grade 3 or Grade 4 spondylolisthesis, nephrolithiasis, etc.). 6.Concurrent use of NSAIDs or any type of medication having analgesic effect (including topical treatment) from baseline visit throughout study treatment. 7.Use of muscle-relaxant medication within 14 days of the baseline visit or during the treatment period. 8.Concomitant use of other analgesic methods during the treatment period (massage, physiotherapy, balneotherapy, etc.). 9.Neurologic alteration of different origin which – according to the investigator’s opinion - significantly affects the sensory or motoric functions (e.g. diabetic neuropathy, multiple sclerosis, dysimmun neuropathies, myopathies of any kind). 10.Known osteoporosis. 11.Known myasthenia gravis. 12.Evidence of any other disease, metabolic or psychological dysfunction, physical examination findings or clinical laboratory finding giving reasonable suspicion of a disease or condition that can significantly interfere with the low back pain or generate unresolved considerations in its differential. 13.Known hypersensitivity to any of the following: tolperisone or to the chemically similar eperisone, ibuprofen, lidocaine, or any ingredients of the study medications. 14.Known severe asthma, attacks of asthma, urticaria, or acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs in Medical History. 15.Known severe liver or renal insufficiency. 16.Haematopoetic or haemolytic disorders of unknown origin 17.Known coagulation disorder, or concomitant intake of anticoagulant medication or medication inhibiting platelet aggregation. 18.Active or history of peptic ulcer / haemorrhage. Active gastric or intestinal ulcer, bleeding or perforation. 19.History of gastro-intestinal bleeding or perforation. 20.Known ulcerative colitis or Crohn’s disease. 21.Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 22. The presence of significant cardiovascular risk factors (eg. hypertension, hypelipidaemia, diabetes mellitus, smoking) that in the opinion of the investigator would prevent use of ibuprofen. 23.History of drug or alcohol abuse within the past 2 years or current chronic or intermittent users of illicit drugs. 24.Lactating or pregnant women or women of child-bearing potential without appropriate contraceptive treatment. 25.Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate at the necessary level. 26.Evidence of an uncooperative attitude. 27.Participation in another clinical trial with any investigational drug or medical device within 1 month or 5x half-life of the investigational drug prior to baseline visit of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether tolperisone, when administered with standardized NSAID treatment to patients with acute non-specific low back pain is effective in reducing pain.;Secondary Objective: To determine whether tolperisone, when administered with standardized NSAID is effective for the treatment of patients with acute non-specific low back pain. To determine the effect of tolperisone treatment in patients with acute non-specific low back pain on quality of life and absenteeism. To determine the effect of tolperisone on recurrence of low-back pain and rebound of event. To assess the safety profile of tolperisone, when administered with standard NSAID.;Primary end point(s): The change in pain VAS score from Baseline to Day 5.;Timepoint(s) of evaluation of this end point: Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The change in Finger-to-Floor Distance (FFD) from Baseline throughout the study (Day 3, 5, 7 and 14). •The change in the result of Lumbar Spine Side Flexion test from Baseline throughout the study (Day 3, 5, 7 and 14). •The change in Roland-Morris Disability Questionnaire (RMDQ) score from Baseline throughout the study (Day 3, 5, 7 and 14). •The change in pain VAS scores (pain at rest) from Baseline throughout the study assessed by the patient daily in the Patient Diary. •The change in pain VAS scores (pain at rest and pain on movement) from Baseline throughout the study assessed during clinic visits. •The Sum of Pain Intensity Differences (SPID): the area under the time-analgesic effect curve for pain intensity from baseline to Day 3, 5, 7 and 14. •The amount of rescue medication taken by the patient and recorded in the patient diary. •The value of physician’s global assessment of the treatment (PhGA) throughout the study (Day 3, 5, 7 and 14). •The value of Patient’s Global Impression of improvement (PGIC-I) •Responder rate at Day 3, 5, 7 and 14. A patient is considered responder if the absolute change in VAS score from baseline is >=3.5 cm. •The change in quality of life (EQ-5D) scores from Baseline throughout the study (Day 3, 5, 7 and 14). •Days of absenteeism from work from Baseline to Day 14. •Number of recurrences until the 3 months follow-up visit. •Safety profile will be evaluated by the assessment of adverse events, ECG, vital signs (pulse and blood pressure), routine laboratory parameters, and physical examination.;Timepoint(s) of evaluation of this end point: Day 3, Day5, Day 7, Day 14, 3 months | — |
Countries
Hungary
Contacts
Public ContactCRO
Cortex Pharma Services
Outcome results
None listed