Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee

NCT02554552 | Withdrawn Phase 1 DMC

• 1 other identifier: YY_YY1201_001/2a
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YY1201 for treatment of osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Variation of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline

  Week 4 and Week 12

Secondary Outcomes (11)

• Variation of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline

  Week 4 and Week 12

• Variation of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline

  Week 4 and Week 12

• Motion pain (100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline

  Week 4 and Week 12

• Patient global assessment (100mm-VAS) on the 4, 12 weeks after administration with baseline

  Week 4 and Week 12

• Investigator global assessment (100mm-VAS) on the 4, 12 weeks after administration

  Week 4 and Week 12

Study Arms (4)

YY1201 2ml

EXPERIMENTAL

YY1201 2ml

Drug: YY1201 2ml

YY1201 3ml

EXPERIMENTAL

YY1201 3ml

Drug: YY1201 3ml

Placebo 2ml

PLACEBO COMPARATOR

Phosphate buffered saline 2ml

Drug: Placebo 2ml

Placebo 3ml

PLACEBO COMPARATOR

Phosphate buffered saline 3ml

Drug: Placebo 3ml

Interventions

YY1201 2ml DRUG

YY1201 2ml

YY1201 2ml

Placebo 2ml DRUG

phosphate buffered saline 2ml

Also known as: Placebo comparator 1

Placebo 2ml

YY1201 3ml DRUG

YY1201 2ml

YY1201 3ml

Placebo 3ml DRUG

phosphate buffered saline 3ml

Also known as: Placebo comparator 2

Placebo 3ml

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or Females 40 years and older
• 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
• bony tenderness
• Bony enlargement
• Nopalpable warmth of synvium
• Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I\~III by the radioactive examination.
• 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
• Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
• 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.)
• Patient who agrees to participate in this clinical trial by themselves.

You may not qualify if:

• Someone who has BMI≥32kg/m² at the screening visit.
• Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
• 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.
• Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
• Patient who has rheumarthritis or other inflammatory metabolic arthritis.
• Patients having serious gastrointestinal, liver, renal, heart disease.
• When the inflammatory disease is occurred on joint area to patient like septic arthritis.
• Patients having skin ailment at the injecting site of the joint region.
• Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
• Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
• Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
• Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
• 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.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chul-Won Ha, M.D.

  Samsung Medical Center, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

KR (1)