Acute low back pain MedDRA version: 17.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Product Name: Tizaspray
Product Code: Tizaspray
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Tizanidine hydrochloride
CAS Number: 64461-82-1
Current Sponsor code: Tizaspray
Other de
Sponsors
MDM S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old 2. Average low back pain intensity moderate to severe (= 60 mm in the VAS) at Visit 1 3. Positivity to Schober test (i.e. measure =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. History of chronic low back pain 2. Current treatment with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine) 3. Current treatment with any other muscle relaxant or any drugs having muscle relaxant properties 4. Known allergies, hypersensitivity, or intolerance to tizanidine or paracetamol or any excipients used in their manufacture (included patients with known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption) 5. Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety 6. Evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study 7. Spinal surgery within 1 year of study entry 8. Evidence of clinical gastrointestinal malabsorption 9. Use of steroids within 3 months of study entry or any other long-term treatment with steroids 10. Use of NSAID’s or other anti-inflammatory drugs 6 hours prior to study inclusion 11. Use of fluvoxamine or ciprofloxacin, or other inhibitors of CYP1A2 such as antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, and ticlopidine 12. Use of hypnotics or other CNS depressants 13. Blood pressure <100/70 mmHg and/or treated with antihypertensive drug 14. History of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis 15. Severe scoliosis 16. More severe pain in a region other than the lower back 17. Acute low back pain associated with chills or fever 18. Pregnancy, breast feeding 19. Treatment with another investigational agent within the last 30 days 20.Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the “hand-to-floor” distance at baseline, day 3 and day 8.2)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets as assessed by the Low Back Pain Intensity Scale (VAS) over maximum 7 days of treatment. 3)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the Schober test (positive/negative) at baseline, day 3 and day 8.;Secondary Objective: 1)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets as assessed by the Patient’s Pain Relief Evaluation on days 3 and 8. 2)To determine the efficacy of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets at 30, 60, 90 and 180 minutes after the second administration (on day 1, 2 and 3) as assessed by the Low Back Intensity Scale (0 to 100 mm VAS).3)To evaluate the efficacy of Tizaspray 0.5 mg for the treatment of acute low back pain compared to Sirdalud 2 mg tablets, as measured by the Roland Disability Questionnaire on days 3 and 8.4)To evaluate the muscle relaxant activity of Tizaspray 0.5 mg compared to Sirdalud 2 mg tablets as assessed by the Schober test difference in cm between day 1 and day 3 and between day 1 and day 8.5)To evaluate the use of rescue medication for low back pain. Safety Objectives: To investigate the systemic, local safety and tolerability of Tizaspray 0.5 mg administered t.i.d.;Primary end point(s): 1) “Hand-to-floor” distance (evaluated at day 1, day 3 and day 8) 2) Low Back Pain Intensity Scale (0 to 100 mm VAS) over 7 days of treatment: daily evaluations of the pain intensity during movement, at rest and at night through the patient’s diary and evaluation of the pain intensity at visits. 3) Proportion of subjects with negative Schober test at day 3 and day 8 ;Timepoint(s) of evaluatio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Patient’s Pain Relief Evaluation (improvement in pain from baseline to days 3 and 8) 2) Low Back Pain Intensity Scale (0 to 100 mm VAS) at 30, 60, 90 and 180 minutes after the second administration on days 1, 2 and 3 3) Roland Disability Questionnaire (RDQ) score on day 1, day 3 and day 8 4) Schober test difference in cm between day 1 and day 3 and between day 1 and day 8 5) Use of “rescue medication” (paracetamol) for low back pain Safety / tolerability endpoints: 1) Incidence, type, and severity of adverse events 2) Laboratory tests changes, in terms of normal, abnormal non-clinically significant and abnormal clinically significant values 3) Patient’s Global Tolerability Evaluation assessed on day 8 ;Timepoint(s) of evaluation of this end point: 1) At day 3 and day 8 2) After the second administration on days 1, 2 and 3 3) At day 1, day 3 and day 8 4) At day 1, day 3 and day 8 5) At day 8 Safety / tolerability endpoints: 1) At day 1, day 3 and day 8 2) At day 1 and day 8 3) At day 8 | — |
Countries
Italy
Contacts
Public ContactServizio Segreteria MDM
MDM S.p.A.
Outcome results
None listed