Clinical trial NCT02934061: Study to Assess the Efficacy and Safety of Tizaspray® Versus Sirdalud®, in Patients With Acute Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Acute low back pain
Lead sponsor: MDM S.p.A.
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
name: Latis S.r.l.
First posted: 2016-10-14
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open label, randomized, controlled, multicenter study with two parallel groups of patients

Detailed description: 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.

Eligibility 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 \< 5 cm) at Visit 1
4. 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
5. 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
6. Signed Informed Consent

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
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

Primary outcomes:
measure: "hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
timeFrame: days: 1
Secondary outcomes:
measure: "hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
timeFrame: days: 3
measure: "hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
timeFrame: days: 8
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Opera Contract Research Organization SRL
state: Timis
Study officials:
affiliation: SCM GADOS
name: Doina Rosu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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