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Trial record 2 of 2 for:    Techfields | Osteoarthritis, Knee

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

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ClinicalTrials.gov Identifier: NCT03081806
Recruitment Status : Not yet recruiting
First Posted : March 16, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Techfields Pharma Co. Ltd

Brief Summary:
This is a Phase 3, Multicenter, 12-Week, double-blind and 40-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 Knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: X0002 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, 12-Week, Double-Blind and 40-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 Knee
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active drug
X0002, BID (approximately every 12 hours; n=400)
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, 4, 8, 12 visits) are show in Study Flow Chart of Double-blind Period, and the open label period will be started from the Week 12 visit (see Table 2). All subjects treated with active drug or placebo complete the 12-week double-blind study will enter this Open-label study and will be treated with active drug, X0002.
Placebo Comparator: Placebo
Placebo, BID (approximately every 12 hours; n=200)
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, 4, 8, 12 visits) are show in Study Flow Chart of Double-blind Period, and the open label period will be started from the Week 12 visit (see Table 2). All subjects treated with active drug or placebo complete the 12-week double-blind study will enter this Open-label study and will be treated with active drug, X0002.



Primary Outcome Measures :
  1. WOMAC pain subscale score in the target knee at Week 12 [ Time Frame: Week 12 ]
    To evaluate the effect of X0002 spray compared to placebo for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at Week 12.


Secondary Outcome Measures :
  1. WOMAC pain subscale score in the target knee at 2, 4, 8, 22, 32, 42, and 52 weeks of treatment. [ Time Frame: Week 2, 4, 8, 22, 32, 42, and 52 ]
    To evaluate the effect of X0002 spray for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at 2, 4, 8, 22, 32, 42, and 52 weeks of treatment.

  2. WOMAC stiffness subscale score in the target knee [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    To evaluate the effect of X0002 spray for the relief of joint stiffness in subjects with OA of the knee as measured by the WOMAC stiffness subscale score in the target knee.

  3. WOMAC functional ability subscale score in the target knee [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    To evaluate the effect of X0002 spray on difficulty performing daily activities in subjects with OA of the knee as measured by the WOMAC functional ability subscale score in the target knee.

  4. Overall WOMAC (VAS) score in the target knee [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    To evaluate the effect of X0002 spray in subjects with OA of the knee as measured by the overall WOMAC (VAS) score in the target knee.

  5. Change of radiographic joint space [ Time Frame: Week 12 and Week 52 ]
    To evaluate the efficacy of X0002 spray in change of radiographic joint space (at standardized locations in the medial and lateral compartments) of the target knee of subjects with osteoarthritis (OA) of the knee as measured by X-ray.

  6. Changes of MOAKS [ Time Frame: Week 12 and 52 ]
    To evaluate the efficacy of X0002 spray in changes of MOAKS28 (see Appendix 5) scale of subjects with osteoarthritis (OA) of the knee as measured by quantitative magnetic resonance imaging (3D qMRI) of femur, tibia and patella periarticular bone area.

  7. Change of cartilage thickness [ Time Frame: Week 12 and 52 ]
    To evaluate the efficacy of X0002 spray in change of cartilage thickness (at standardized locations in the femur, tibia and patella compartments) of subjects with osteoarthritis (OA) of the knee as measured by quantitative magnetic resonance imaging (3D qMRI) of femur, tibia and patella periarticular bone area.

  8. Subject's global assessment of disease status of the target knee [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.

  9. Subject's global assessment of response to therapy of the target knee [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.

  10. The amount of rescue medication [ Time Frame: Week 2, 4, 8, 12, 22, 32, 42, and 52 ]
    To assess change from Baseline in the amount of rescue medication (acetaminophen) consumed per day for target knee pain in subjects with OA of the knee.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to read and 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 50 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.
  5. Subject must have a body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.
  6. Subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and fulfillment of at least one of the 3 criteria:

    • age of ≥50 years
    • stiffness lasting <30 minutes after getting up in the morning
    • crepitus
  7. A subject must have a Kellgren Lawrence Grade of 1, 2 or 3 as determined by a central radiologist at the first screening visit.
  8. Subject must have a history of clinically symptomatic OA of the knee for ≥6 months.
  9. Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to Screening.
  10. Subject must have a knee 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 be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting on 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 4, Week 8, Week 12, Week 22, Week 32, Week 42, and Week 52/EOS.
  12. 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 lower limbs 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.)
  13. Subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study starting on the first screening visit.
  14. With the exception of OA of the knee, 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:

    1. A metal device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator);
    2. Have history of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they sought medical attention;
    3. Have claustrophobia;
    4. Have difficulty fitting into the MRI knee coil due to greater than normal thigh diameter.
  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 knee or OA of lower limb joints other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee.
  5. Subject who has OA of the knee with a Kellgren Lawrence 1> Grade >3 as determined by the Investigator or a local radiologist at Screening.
  6. Subject who failed in collecting consistent and standardized PA Fixed Flexion XR for quantitative analysis.
  7. Subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee.
  8. Subject who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before Screening.
  9. Subject who has skin lesions or wounds on or near the knees to be treated at Screening or on Day 1 prior to the first administration of study medication.
  10. Subject who has used opiates or corticosteroids within 30 days before Screening for the target knee or who requires treatment with chronic opiates or corticosteroids.
  11. Subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (eg, Synvisc®) to a knee to be treated within the 3 months before Screening.
  12. Subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen.
  13. Subject with a BMI >40.
  14. 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.
  15. Subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening.
  16. Subject who has positive results on fecal occult blood testing at Screening or on Day 1 prior to the first administration of study medication.
  17. Subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (eg, osteonecrosis, chondrocalcinosis).
  18. Subject is an asthmatic requiring treatment with systemic corticosteroids. Asthmatic subjects using inhaled corticosteroids are eligible.
  19. 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.
  20. 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).
  21. Subject has any other clinically significant laboratory finding at Screening that in the investigator's opinion contraindicates study participation.
  22. 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).
  23. Subject has clinically significant abnormality on 12-lead ECG, including a QTcF interval >450 milliseconds for males and 470 msec for females.
  24. Subject has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at baseline (may be repeated after 5 minutes rest to verify).
  25. Subject is female and pregnant, planning to become pregnant during the study, or nursing.
  26. Subject has tested positive on the urine drug screen.
  27. Subject participated in a previous clinical study with X0002.
  28. Subjects with known alcohol or other substance abuse.
  29. Subject participated in any other clinical trial within the past 3 months or 5 half-lives, whichever is longer.
  30. Subject is a participating Investigator, sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned.
  31. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
  32. Subjects without access to telephone and/or ability to gain technology access.

Responsible Party: Techfields Pharma Co. Ltd
ClinicalTrials.gov Identifier: NCT03081806     History of Changes
Other Study ID Numbers: TF-X0002-31
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: October 2017
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

Keywords provided by Techfields Pharma Co. Ltd:
Phase 3
Efficacy
Safety
Osteoarthritis, Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases