Back to resultsStudy to Assess the Efficacy and Safety of Tizaspray® Versus Sirdalud®, in Patients With Acute Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Tizaspray® administered intranasally
Sirdalud® 2 mg tablets administered
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Acute low back pain
Eligibility Criteria
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
Sites / Locations
- Opera Contract Research Organization SRL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tizaspray®
Sirdalud®
Arm Description
Tizaspray® administered intranasally in patients with acute low back pain
Sirdalud® 2 mg tablets administered in patients with acute low back pain
Outcomes
Primary Outcome Measures
"hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
Secondary Outcome Measures
"hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
"hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
Full Information
NCT ID
NCT02934061
First Posted
October 7, 2016
Last Updated
January 12, 2018
Sponsor
MDM S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company, Latis S.r.l.
1. Study Identification
Unique Protocol Identification Number
NCT02934061
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MDM S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company, Latis S.r.l.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Acute low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tizaspray®
Arm Type
Experimental
Arm Description
Tizaspray® administered intranasally in patients with acute low back pain
Arm Title
Sirdalud®
Arm Type
Active Comparator
Arm Description
Sirdalud® 2 mg tablets administered in patients with acute low back pain
Intervention Type
Device
Intervention Name(s)
Tizaspray® administered intranasally
Other Intervention Name(s)
Tizaspray®
Intervention Description
0,5 mg Tizaspray® administered intranasally
Intervention Type
Drug
Intervention Name(s)
Sirdalud® 2 mg tablets administered
Other Intervention Name(s)
Sirdalud®
Intervention Description
Sirdalud® 2 mg tablets administered in patients with acute low back pain
Primary Outcome Measure Information:
Title
"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 Measure Information:
Title
"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
Title
"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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doina Rosu, MD
Organizational Affiliation
SCM GADOS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Opera Contract Research Organization SRL
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300209
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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17852259
Citation
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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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