A randomized double blind placebo controlled multicenterstudy to assess the efficacy and tolerability of tolperisone as add ontreatment with standardized NSAID of acute non specific low back pain.

Phase 1

• Conditions: Acute, non-specific low back pain; MedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-006042-13-HU
• Lead Sponsor: MEDITOP Gyógyszeripari Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-14
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 355

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified