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

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ClinicalTrials.gov Identifier: NCT02934061
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Opera Contract Research Organization SRL
Latis S.r.l.
Information provided by (Responsible Party):
MDM S.p.A.

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

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Tizaspray® administered intranasally Drug: Sirdalud® 2 mg tablets administered Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Tizaspray®
Tizaspray® administered intranasally in patients with acute low back pain
Device: Tizaspray® administered intranasally
0,5 mg Tizaspray® administered intranasally
Other Name: Tizaspray®

Active Comparator: Sirdalud®
Sirdalud® 2 mg tablets administered in patients with acute low back pain
Drug: Sirdalud® 2 mg tablets administered
Sirdalud® 2 mg tablets administered in patients with acute low back pain
Other Name: Sirdalud®




Primary Outcome Measures :
  1. "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 Outcome Measures :
  1. "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 ]
  2. "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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934061


Locations
Romania
Opera Contract Research Organization SRL
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
MDM S.p.A.
Opera Contract Research Organization SRL
Latis S.r.l.
Investigators
Principal Investigator: Doina Rosu, MD SCM GADOS

Publications:

Responsible Party: MDM S.p.A.
ClinicalTrials.gov Identifier: NCT02934061     History of Changes
Other Study ID Numbers: TZSA2
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MDM S.p.A.:
Acute low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tizanidine
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympatholytics