Study to Assess the Efficacy and Safety of Tizaspray® Versus Sirdalud®, in Patients With Acute Low Back Pain

Study Overview
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Brief Summary
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Open label, randomized, controlled, multicenter study with two parallel groups of patients

Detailed Description
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This is a phase III, open label, randomized, controlled, multicenter study with two parallel groups of patients. Tizaspray® 0.5 mg (a new pharmaceutical form, liquid nasal spray solution), is proposed in this trial as a ready to use treatment for short term therapy of painful muscle spasms as the acute low back pain.

Official Title
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A Phase III, Multicenter, Randomized Study to Assess the Efficacy and Safety of 0,5 mg Tizaspray® Administered Intranasally Versus Sirdalud® 2 mg Tablets, in Patients With Acute Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Tizaspray® administered intranasally
* Drug: Sirdalud® 2 mg tablets administered


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years old Average low back pain intensity moderate to severe (≥ 60 mm in the VAS) at Visit 1 Positivity to Schober test (i.e. measure < 5 cm) at Visit 1 Acute low back pain started at least 24 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain Negative pregnancy test for women of childbearing potential (to be performed at Visit 1) and use of an acceptable mean of contraception (condom or mechanical methods) in the previous 2 months and for whole duration of the study Signed Informed Consent Exclusion Criteria: History of chronic low back pain Current treatment with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine) Current treatment with any other muscle relaxant or any drugs having muscle relaxant properties 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) 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 Evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study Spinal surgery within 1 year of study entry Evidence of clinical gastrointestinal malabsorption Use of steroids within 3 months of study entry or any other long-term treatment with steroids Use of NSAID's or other anti-inflammatory drugs 6 hours prior to study inclusion 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 Use of hypnotics or other CNS depressants Blood pressure <100/70 mmHg History of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis Severe scoliosis More severe pain in a region other than the lower back Acute low back pain associated with chills or fever Pregnancy, breast feeding Treatment with another investigational agent within the last 30 days Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tizaspray®<br>Tizaspray® administered intranasally in patients with acute low back pain | Device: Tizaspray® administered intranasally<br>* 0,5 mg Tizaspray® administered intranasally<br>* Other names: Tizaspray®;|
| Active Comparator: Sirdalud®<br>Sirdalud® 2 mg tablets administered in patients with acute low back pain | Drug: Sirdalud® 2 mg tablets administered<br>* Sirdalud® 2 mg tablets administered in patients with acute low back pain<br>* Other names: Sirdalud®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand-to-floor distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ) |  | days: 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand-to-floor distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ) |  | days: 3 | 
| hand-to-floor distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ) |  | days: 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute low back pain