Clinical Trial: A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Lumbar Spine

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, 20-Week, Double-Blind and 32-Week Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in Relief of the Signs and Symptoms of Subjects With Osteoarthritis of the

Brief Summary: This is a Phase 3, Multicenter, Randomized, 20 Week, Double-Blind, Placebo Controlled and 32-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of the low back.

Detailed Summary:

After a Screening Period, a subject will be randomly assigned to 1 of 2 treatment groups in a 2:1 ratio of active: placebo (ie, 2 subjects to active treatment and 1 subject to placebo) and stratified evenly according to Modified Pfirrmann Grading system grade 3, 4, 5, or 6, gender, BMI (30≤vs.>30), and age (65≤vs.>65). Before the first screening visit, there is a pre-Screening Telephone Call or email interview, the Screening Period of at least 14 days up to 3 weeks will consist of two visits for the assessment of eligibility including radiographic evaluation of the low back. All tasks at screening visits and week 2, 5, 10, 15, and 20 visits are listed in Study Flow Chart of Double-blind Period and the open label period will be started from the Week 20 visit.

Subjects taking nonsteroidal anti-inflammatory drugs (NSAID) or other analgesics may enroll in the trial, but will discontinue any analgesic therapy for the duration of the study, starting at the first screening visit. Subjects will be allowed to take rescue medication (up to six 325 mg tablets [total of 1950 mg] of acetaminophen per day; provided by the Sponsor) for residual low back or other body pain starting at the first screening visit during screening and treatment periods except during the 24 hours prior to the second Screening visit, Baseline (Day 1), Week 2, Week 5, Week 10, Week 15, Week 20, Week 30, Week 40, and Week 52 (EOS).

Subjects will record the following information in a Daily eDiary starting at the first Screening visit: the amount of low back pain while standing, walking, and/or in motion during the preceding 24 hours (using a 100 mm visual analog scale [VAS]), Oswestry Low Back Pain Disability Questionnaire, the times and number of sprays for each administration of study medication (starting at the first screening visit), the time
Sponsor: Techfields Pharma Co. Ltd

Current Primary Outcome: The Oswestry Low Back Pain Disability Questionnaire at week 20 [ Time Frame: Week 20 ]

To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of the low back as measured by the Oswestry Low Back Pain Disability Questionnaire.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The Oswestry Low Back Pain Disability questionnaire at Week 2, 5, 10, 15, 30, 40, and 52 [ Time Frame: Week 2, 5, 10, 15, 30, 40, and 52 ]
    To evaluate the efficacy of X0002 spray for the relief of low back pain disability in subjects with osteoarthritis (OA) of the lumbar spine as measured by the Oswestry Low Back Pain Disability questionnaire.
  • The Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To evaluate the effect of X0002 spray on health outcomes in subjects with OA of the lumbar spine as measured by the Short-Form 36-Item Health Survey Version 2.0 (SF-36v2).
  • The Modified Brief Pain Inventory (mBPI) Severity Score [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To evaluate the effect of X0002 spray for the relief of low back pain in subjects with OA of the lumbar spine as measured by the Modified Brief Pain Inventory (mBPI) Severity Score.
  • The Modified Brief Pain Inventory (mBPI) Interference Score [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To evaluate the effect of X0002 spray in subjects with OA of the lumbar spine as measured by the Modified Brief Pain Inventory (mBPI) Interference Score.
  • Degenerative changes measured by the modified Pfirrmann scoring by magnetic resonance imaging (3D qMRI) [ Time Frame: Screening visit, Week 20, and Week 52 ]
    To evaluate change at Week 20 and 52 in degenerative changes (the worst vertebral level) in lumbar spinal discs in subjects with OA of the lumbar spine as measured by the modified Pfirrmann scoring by magnetic resonance imaging (3D qMRI).
  • Modic Change measured by magnetic resonance imaging (3D qMRI) [ Time Frame: Screening visit, Week 20, and Week 52 ]
    To evaluate change at Week 20 and 52 in Modic Change in subjects with OA of the lumbar spine as measured by magnetic resonance imaging (3D qMRI).
  • Facet Osteoarthritis Change measured by quantitative magnetic resonance imaging (3D qMRI) [ Time Frame: Screening visit, Week 20, and Week 52 ]
    To evaluate change at Week 20 and 52 in Facet Osteoarthritis Change in subjects with OA of the lumbar spine as measured by quantitative magnetic resonance imaging (3D qMRI).
  • The change in the Pain Visual Analog Scale (VAS) Score [ Time Frame: Screening visit, Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To evaluate the effect of X0002 spray in subjects with OA of the lumbar spine as measured by the change in the Pain Visual Analog Scale (VAS) Score.
  • Disease status (global assessment) [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To assess the Subject's global assessment of disease status at Week 2, 5, 10, 15, 20, 30, 40, and 52 in subjects with OA of the lumbar spine.
  • The Subject's Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To assess the Subject's Clinical Global Impression-Improvement (CGI-I) at Week 2, 5, 10, 15, 20, 30, 40, and 52 in subjects with OA of the lumbar spine.
  • The amount of rescue medication [ Time Frame: Week 2, 5, 10, 15, 20, 30, 40, and 52 ]
    To assess the amount of rescue medication (acetaminophen) consumed per day for low back pain at Week 2, 5, 10, 15, 20, 30, 40, and 52 in subjects with OA of the lumbar spine.


Original Secondary Outcome: Same as current

Information By: Techfields Pharma Co. Ltd

Dates:
Date Received: March 10, 2017
Date Started: July 10, 2017
Date Completion: August 30, 2019
Last Updated: April 12, 2017
Last Verified: March 2017