Low Back PainPhase 3NCT02934061

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

A Phase 3 study testing Tizaspray® administered intranasally and Sirdalud® 2 mg tablets administered in people with Low Back Pain, run by MDM S.p.A. at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Open label, randomized, controlled, multicenter study with two parallel groups of patients Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: Tizaspray® administered intranasally and Sirdalud® 2 mg tablets administered
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 siteRomania
Study dates: Oct 2016to Feb 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

1 site in 1 country.

Romania1 site

Opera Contract Research Organization SRL
Timișoara, Timiș County, 300209

Other trials in Romania

About this study

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

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

Read the 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.

Conditions: Low Back Pain
Being tested: Tizaspray® administered intranasally, Sirdalud® 2 mg tablets administered
Keywords: Acute low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tizaspray® administered intranasallyDevice
Also called Tizaspray®
0,5 mg Tizaspray® administered intranasally
Sirdalud® 2 mg tablets administeredDrug
Also called Sirdalud®
Sirdalud® 2 mg tablets administered in patients with acute low back pain

Study groups in NCT02934061
Study group	Role	What they receive
Tizaspray®	Experimental	Tizaspray® administered intranasally in patients with acute low back pain Receives: Device: Tizaspray® administered intranasally
Sirdalud®	Active comparator	Sirdalud® 2 mg tablets administered in patients with acute low back pain Receives: Drug: Sirdalud® 2 mg tablets administered

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Feb 2017

First posted14 Oct 2016 (estimated)
Study startOct 2016
Primary completionJan 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02934061
Sponsor's protocol ID: TZSA2
Status last verified: Mar 2017
First submitted: 7 Oct 2016
Last updated: 16 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Liddle SD, Baxter GD, Gracey JH. Chronic low back pain: patients' experiences, opinions and expectations for clinical management. Disabil Rehabil. 2007 Dec 30;29(24):1899-909. doi: 10.1080/09638280701189895. Epub 2007 May 4.
PubMed 17852259
Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. doi: 10.1056/NEJM198802043180506. No abstract available.
PubMed 2961994
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(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
PubMed 16550447
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.
PubMed 18727454
Gorska J. [Effects of back pain treatment with tizanidine]. Ortop Traumatol Rehabil. 2005 Jun 30;7(3):306-9. Polish.
PubMed 17611479
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. doi: 10.1016/j.coem.2006.03.002.
PubMed 16963380
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. doi: 10.1097/01.brs.0000128258.49781.74.
PubMed 15187636
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. doi: 10.1097/00007632-199612150-00004.
PubMed 9112707
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.
PubMed 18177783
Vitale DC, Piazza C, Sinagra T, Urso V, Cardi 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.
PubMed 24085590
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. doi: 10.1097/00000539-199604000-00024.
PubMed 8615503
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. doi: 10.1177/030006058801600202.
PubMed 2967781
Fryda-Kaurimsky Z, Muller-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. doi: 10.1177/030006058100900613.
PubMed 6459256
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. doi: 10.1177/030006058100900111.
PubMed 6451461
van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low back pain. Cochrane Database Syst Rev. 2003;2003(2):CD004252. doi: 10.1002/14651858.CD004252.
PubMed 12804507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02934061
Acronym / sponsor ID: TZSA2
Conditions: Low Back Pain
Keywords: Acute low back pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: MDM S.p.A.University, hospital or other
Collaborators: Opera CRO, a TIGERMED Group Company, Latis S.r.l.
Study start: Oct 2016 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 14 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tizaspray®	Experimental	Device: Tizaspray® administered intranasallyTizaspray® administered intranasally in patients with acute low back pain
Sirdalud®	Active comparator	Drug: Sirdalud® 2 mg tablets administeredSirdalud® 2 mg tablets administered in patients with acute low back pain

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tizaspray® administered intranasallyAlso: Tizaspray®0,5 mg Tizaspray® administered intranasally	Device	Tizaspray®
Sirdalud® 2 mg tablets administeredAlso: Sirdalud®Sirdalud® 2 mg tablets administered in patients with acute low back pain	Drug	Sirdalud®

Primary outcome

"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

2 secondary outcomes

"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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Background: PubMed 17852259Liddle SD, Baxter GD, Gracey JH. Chronic low back pain: patients' experiences, opinions and expectations for clinical management. Disabil Rehabil. 2007 Dec 30;29(24):1899-909. doi: 10.1080/09638280701189895. Epub 2007 May 4.
Background: PubMed 2961994Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. doi: 10.1056/NEJM198802043180506. No abstract available.
Background: PubMed 16550447van 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(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
Background: PubMed 18727454Cabitza 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.
Background: PubMed 17611479Gorska J. [Effects of back pain treatment with tizanidine]. Ortop Traumatol Rehabil. 2005 Jun 30;7(3):306-9. Polish.
Background: PubMed 16963380Malanga GA, Dennis RL. Use of medications in the treatment of acute low back pain. Clin Occup Environ Med. 2006;5(3):643-53, vii. doi: 10.1016/j.coem.2006.03.002.
Background: PubMed 15187636Bernstein 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. doi: 10.1097/01.brs.0000128258.49781.74.
Background: PubMed 9112707Von 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. doi: 10.1097/00007632-199612150-00004.
Background: PubMed 18177783Henschke 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.
Background: PubMed 24085590Vitale DC, Piazza C, Sinagra T, Urso V, Cardi 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.
Background: PubMed 8615503Miettinen 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. doi: 10.1097/00000539-199604000-00024.
Background: PubMed 2967781Berry 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. doi: 10.1177/030006058801600202.
Individual participant dataSharing planned: Yes

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doina Rosu, MD principal investigator

SCM GADOS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tizaspray® administered intranasally and Sirdalud® 2 mg tablets administered in people with Low Back Pain, run by MDM S.p.A. at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02934061, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.