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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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.

Interventions

  • Device: Tizaspray® administered intranasally
    • 0,5 mg Tizaspray® administered intranasally
  • Drug: Sirdalud® 2 mg tablets administered
    • Sirdalud® 2 mg tablets administered in patients with acute low back pain

Arms, Groups and Cohorts

  • Experimental: Tizaspray®
    • Tizaspray® administered intranasally in patients with acute low back pain
  • Active Comparator: Sirdalud®
    • Sirdalud® 2 mg tablets administered in patients with acute low back pain

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MDM S.p.A.
  • Collaborator
    • Opera CRO, a TIGERMED Group Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Doina Rosu, MD, Principal Investigator, SCM GADOS

References

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Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. Review.

van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2:S169-91.

Cabitza P, Randelli P. Efficacy and safety of eperisone in patients with low back pain: a double blind randomized study. Eur Rev Med Pharmacol Sci. 2008 Jul-Aug;12(4):229-35.

Górska J. [Effects of back pain treatment with tizanidine]. Ortop Traumatol Rehabil. 2005 Jun 30;7(3):306-9. Polish.

Malanga GA, Dennis RL. Use of medications in the treatment of acute low back pain. Clin Occup Environ Med. 2006;5(3):643-53, vii. Review.

Bernstein E, Carey TS, Garrett JM. The use of muscle relaxant medications in acute low back pain. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1346-51.

Von Korff M, Saunders K. The course of back pain in primary care. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2833-7; discussion 2838-9. Review.

Henschke N, Maher CG, Refshauge KM. A systematic review identifies five "red flags" to screen for vertebral fracture in patients with low back pain. J Clin Epidemiol. 2008 Feb;61(2):110-118. doi: 10.1016/j.jclinepi.2007.04.013. Epub 2007 Aug 27. Review.

Vitale DC, Piazza C, Sinagra T, Urso V, Cardì F, Drago F, Salomone S. Pharmacokinetic characterization of tizanidine nasal spray, a novel intranasal delivery method for the treatment of skeletal muscle spasm. Clin Drug Investig. 2013 Dec;33(12):885-91. doi: 10.1007/s40261-013-0137-2.

Miettinen TJ, Kanto JH, Salonen MA, Scheinin M. The sedative and sympatholytic effects of oral tizanidine in healthy volunteers. Anesth Analg. 1996 Apr;82(4):817-20.

Berry H, Hutchinson DR. Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice. J Int Med Res. 1988 Mar-Apr;16(2):83-91.

Fryda-Kaurimsky Z, Müller-Fassbender H. Tizanidine (DS 103-282) in the treatment of acute paravertebral muscle spasm: a controlled trial comparing tizanidine and diazepam. J Int Med Res. 1981;9(6):501-5.

Hennies OL. A new skeletal muscle relaxant (DS 103-282) compared to diazepam in the treatment of muscle spasm of local origin. J Int Med Res. 1981;9(1):62-8.

van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low back pain. Cochrane Database Syst Rev. 2003;(2):CD004252. Review.

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