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

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ClinicalTrials.gov Identifier: NCT03110523
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Techfields Pharma Co. Ltd

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Lumbar Spine Drug: X0002 Drug: Placebo Phase 3

Detailed Description:

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 times when the subject washes his/her low back and/or takes a shower, the number of tablets of rescue medication taken that day and the times taken, the reason for taking the rescue medication (eg, low back pain, headache, knee pain, hip pain), any other concomitant medications taken that day, the use of Curél Itch Defense Lotion, and any AEs occurring that day. The study treatment may cause dry and/or itchy skin; therefore, Curél Itch Defense Lotion (available at any pharmacy) can be applied to treat the affected area and recorded in the diary.

Low back pain disability as assessed by Oswestry Low Back Pain Disability questionnaire will be used for the Primary Efficacy Endpoints. Theses Efficacy endpoints will be assessed at Screening, Day 1 (Baseline) and at Week 2, Week 5, Week 10, Week 15, Week 20, Week 30, Week 40, and Week 52(EOS). Lumbar spine joint space, the K-L scoring, degenerative changes, Disc height and lordosis changes, cartilage thickness, in intervertebral kinematics changes, bone marrow lesion volume and size, disc compositional changes, Pain Visual Analog Scale (VAS) Score, mBPI-Severity Score, mBPI Interference Score, will be used for the Secondary Efficacy Endpoints. These Efficacy endpoints will be assessed at Screening and Baseline (Day 1) and at the Week 2, Week 5, Week 10, Week 15, Week 20, Week 30, Week 40, and Week 52(EOS).

Safety assessments will be performed at each visit and will include assessment of AEs, vital signs (blood pressure, pulse rate, and oral temperature), clinical laboratories, physical examination, skin irritation, and electrocardiograms (ECGs) as indicated in the study flow chart.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Lumbar Spine
Estimated Study Start Date : August 10, 2018
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: X0002
X0002, BID, n=500
Drug: X0002
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 target knee joint space, all screening visits and double-blind treatment visit (week 2, 5, 10, 15, and 20 visits) are show in Study Flow Chart of Double-blind Period, and the open label period will be started from the Week 20 visit. All subjects treated with active drug or placebo complete the 20-week double-blind study will enter the Open-label study and will be treated with active drug, X0002 for 32 weeks.
Other Name: X-0002

Placebo Comparator: Placebo
Placebo, BID, n=250
Drug: Placebo
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 target knee joint space, all screening visits and double-blind treatment visit (week 2, 5, 10, 15, and 20 visits) are show in Study Flow Chart of Double-blind Period.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability read and to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures;
  2. An understanding, ability, and willingness to fully comply with study procedures and restrictions;
  3. Subject must be a male or female between 35 and 85 years of age, inclusive;
  4. Female subjects must either not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or be willing to practice at least 1 of the following medically acceptable methods of birth control:

    • Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before study drug administration;
    • Intrauterine device;
    • Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
  5. Subject must have a body mass index between 18.5 and 40.0 kg/m2, inclusive;
  6. Subject must have X-ray and MRI findings comparable with lumbar degenerative/osteoarthritic changes.
  7. Subject must have the Kellgren-Lawrence (K-L) system grading indexes to disc degeneration in the spine of 1, 2 or 3 as determined by a central radiologist at Screening;
  8. Subject must have the Modified Pfirrmann Grading system scores to disc degeneration in the spine of 3, 4, 5, or 6 as determined by a central radiologist at Screening;
  9. Subject must have had low back pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening;
  10. Subject must have a low back pain score ≥40 mm and <95 mm on a 100 mm VAS (without analgesic medication) on at least 7 of the 10 days prior to randomization;
  11. Subject must have a Oswestry low back pain disability score ≥40 % and <95 % on at least 7 of the 10 days prior to randomization;
  12. Subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting at the first screening visit until completing participation in the study. (The use of ≤325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to the second screening visit, Baseline (Day1), Week 2, Week 5, Week 10, week 15, Week 20, Week 30, Week 40, and Week 52(EOS);
  13. Subject must be willing to discontinue applying any topical preparations containing Vitamin A acids (including all trans retinoic acid (tretinoin), 13 cis retinoic acid [isotretinoin], 9 cis retinoic acid [alitretinoin], vitamin A [retinol], retinal, and their derivatives) to the low back starting on the first screening visit until completing participation in the study. Topical preparations containing Vitamin A acids or retinol may be applied to areas of the skin above the waist, but should not be applied to areas of the skin exposed to study medication;
  14. Subject must be willing to avoid unaccustomed, strenuous physical activity (eg, starting a new weight lifting routine) for the duration of the study. Normal physical activity is allowed.
  15. With the exception of OA of the low back, the subject must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety, or pain and functional assessments, as determined by the Investigator.

Exclusion Criteria:

  1. Subject who have any contraindications to MRI, such as, but not limit to:

    • A metal device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator);
    • Have history of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they sought medical attention;
    • Have claustrophobia;
  2. Subject who has worker's compensation injuries affecting the knee or back;
  3. Subject who is in litigation regarding joint injuries;
  4. Subject who has secondary OA of the low back or OA of lower limb joints other than the low back that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the low back;
  5. Subject who has a history of low back surgery;
  6. Subject who has had significant injury, as judged by the Investigator, involving the low back within the 6 months before Screening;
  7. Subject who has skin lesions or wounds on or near the low back to be treated at Screening or on Day 1 prior to the first administration of study medication;
  8. Subject who has used opiates or corticosteroids within 30 days before Screening or who requires treatment with chronic opiates or corticosteroids;
  9. Subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (eg, Synvisc®) to the low back to be treated within the 3 months before Screening;
  10. Subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen;
  11. Subject with a BMI >40;
  12. Subject who has had an active peptic ulceration in the 6 months prior to Screening or a history of gastrointestinal (GI) bleeding within 5 years of Screening;
  13. Subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening;
  14. Subject who has positive results on fecal occult blood testing at Screening or on Day 1 prior to the first administration of study medication;
  15. Subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, and gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (eg, osteonecrosis, chondrocalcinosis);
  16. Subject is an asthmatic requiring treatment with systemic corticosteroids. Asthmatic subjects using inhaled corticosteroids are eligible;
  17. Subject has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation;
  18. Subject has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥3× the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase, or creatinine ≥1.5× ULN);
  19. Subject has any other clinically significant laboratory finding at Screening that in the investigator's opinion contraindicates study participation;
  20. Subject is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding squamous or basal cell carcinoma of the skin);
  21. Subject has clinically significant abnormality on 12-lead ECG, including a QTcF interval >450 milliseconds for males and 470 msec for females;
  22. Subject has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at baseline (may be repeated 1 additional time after 5 minutes rest to verify). The investigator may, at his discretion, choose to exclude subjects with hypertensive levels lower than these if he deems it in the best interest of the subject;
  23. Subject is female and pregnant, planning to become pregnant during the study, or nursing;
  24. Subject has tested positive on the urine drug screen test;
  25. Subject participated in a previous clinical study with X0002;
  26. Subject participated in any other clinical trial within the past 3 months or 5 half-lives, whichever is longer.
  27. Subjects with known alcohol or other substance abuse;
  28. Subject is a participating Investigator, sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned;
  29. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
  30. Subjects without access to telephone and/or ability to gain technology access.

Responsible Party: Techfields Pharma Co. Ltd
ClinicalTrials.gov Identifier: NCT03110523     History of Changes
Other Study ID Numbers: TF-X0002-32
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Spine
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases