Clinical trial NCT02965495: Clinical Trial of YYD302 for Treatment of Osteoarthritis of the Knee
Official title: A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YYD302 Once in the Treatment of Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee.

Detailed description: phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee

Eligibility criteria: Inclusion Criteria:

1. Males or Females 40 years and older
2. According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.

   * Over 50 years of age
   * Less than 30 minutes of morning stiffness
   * Crepitus on active motion
   * 4 bony tenderness
   * Bony enlargement
   * Nopalpable warmth of synvium
3. Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I\~III by the radioactive examination.
4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm
5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
6. Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.)
7. Patient who agrees to participate in this clinical trial by themselves.

Exclusion Criteria:

1. Someone who has BMI≥32kg/m² at the screening visit.
2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
4. Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.
6. Patients having serious gastrointestinal, liver, renal, heart disease.
7. When the inflammatory disease is occurred on joint area to patient like septic arthritis.
8. Patients having skin ailment at the injecting site of the joint region.
9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
13. Patients who were administrated below drugs before baseline visit.

    * Patients who were injected HA at the target knee joint in recent 9 months.
    * Patients who were injected HA at other parts of the knee joint in recent 6 months.
    * Patients who were injected steroids into the intra-articular knee joint.
    * Patients who were administrated steroids systemically by the oral medication (But, except inhalation)
14. Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test.
15. Patients who have target knee joint gotten surgical operation history including Arthroscopy within past one year (In case of having other side of knee joint or hip joint gotten surgical operation history, excepting the patients if there is possibility which can influence the target knee joint's appraisal.
16. Patients who have an operation history about target knee joint.
17. Patients who do the height weight aerobic exercise or anaerobic exercise.
18. Patients who need to be administrated anticoagulant agent together(But, except 300mg daily dose aspirin)
19. Patients who have hypersensitivity history about Investigational Product.
20. In the midst of women in their childbearing years, patients who disagree to do \* contraception by medically permitted method for 12 weeks from administrating investigational product.

    \* The contraception by medically permitted method: Condom, In case of using injection or insertion, In case of installing a intrauterine contraception device etc.
21. Patients who were injected other investigational product over a time within 30 days before participated in this clinical trail.
22. Besides that, the patients who have difficulty to be participated in this clinical trial continuously by Principle Investigator (PI)'s decision.

Primary outcomes:
measure: Rate of change of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
timeFrame: Change of the week 4 and 12 from baseline
Secondary outcomes:
measure: Rate of change of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline
timeFrame: Week 4 and Week 12
measure: Rate of change of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
timeFrame: Week 4 and Week 12
measure: Motion pain (100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
timeFrame: Week 4 and Week 12
measure: Patient global assessment (100mm-VAS) on the 4, 12 weeks after administration with baseline
timeFrame: Week 4 and Week 12
measure: Investigator global assessment (100mm-VAS) on the 4, 12 weeks after administration
timeFrame: Week 4 and Week 12
measure: Change of the swelling in the knee joint from baseline to 4, 12 weeks after administration
timeFrame: Week 4 and Week 12
measure: Change of the tenderness on pressure in the knee joint from baseline to 4, 12 weeks after administration
timeFrame: Week 4 and Week 12
measure: Variation of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline
timeFrame: Week 4 and Week 12
measure: Use of rescue medication count and the total amount on 4, 12 weeks
timeFrame: Week 4 and Week 12
measure: Response rate of the Weight-bearing pain on 12 weeks in comparison with baseline
timeFrame: Week 12
measure: Response rate of the OMERACT-OARSI on 12 weeks in comparison with baseline
timeFrame: Week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Department of Internal Medicine
name: Chul-Won Ha, M.D
role: PRINCIPAL_INVESTIGATOR
References: