NCT02934061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 16, 2018

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

October 7, 2016

Last Update Submit

January 12, 2018

Conditions

Low Back Pain

Keywords

Acute low back pain

Outcome Measures

Primary Outcomes (1)

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

    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)

    days: 3

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

    days: 8

Study Arms (2)

Tizaspray®

EXPERIMENTAL

Tizaspray® administered intranasally in patients with acute low back pain

Device: Tizaspray® administered intranasally

Sirdalud®

ACTIVE COMPARATOR

Sirdalud® 2 mg tablets administered in patients with acute low back pain

Drug: Sirdalud® 2 mg tablets administered

Interventions

Tizaspray® administered intranasallyDEVICE

0,5 mg Tizaspray® administered intranasally

Also known as: Tizaspray®
Tizaspray®
Sirdalud® 2 mg tablets administeredDRUG

Sirdalud® 2 mg tablets administered in patients with acute low back pain

Also known as: Sirdalud®
Sirdalud®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (15)

  • 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.

    PMID: 17852259BACKGROUND

  • Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. doi: 10.1056/NEJM198802043180506. No abstract available.

    PMID: 2961994BACKGROUND

  • 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.

    PMID: 16550447BACKGROUND

  • 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.

    PMID: 18727454BACKGROUND

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

    PMID: 17611479BACKGROUND

  • 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.

    PMID: 16963380BACKGROUND

  • 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.

    PMID: 15187636BACKGROUND

  • 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.

    PMID: 9112707BACKGROUND

  • 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.

    PMID: 18177783BACKGROUND

  • 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.

    PMID: 24085590BACKGROUND

  • 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.

    PMID: 8615503BACKGROUND

  • 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.

    PMID: 2967781BACKGROUND

  • 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.

    PMID: 6459256BACKGROUND

  • 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.

    PMID: 6451461BACKGROUND

  • 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.

    PMID: 12804507BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doina Rosu, MD

    SCM GADOS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 16, 2018

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

RO(1)