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

January 12, 2018 updated by: MDM S.p.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300209
        • Opera Contract Research Organization SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sirdalud®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
"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
days: 1

Secondary Outcome Measures

Outcome Measure
Time Frame
"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
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
days: 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDM S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company
Latis S.r.l.

Investigators

  • Principal Investigator: Doina Rosu, MD, SCM Gados

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZSA2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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