A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee

This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase II clinical trial and aimed at osteoarthritis of the knee.

Patients who signed informed consent voluntarily and eligible for this study are assigned randomly to one of 3 groups after 2 week-Washout period.

1. st group (experimental) : WIN-34B 450mg BID
2. nd group (experimental) : WIN-34B 900mg BID
3. rd group (Comparator) : Placebo BID

Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4 weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination, questionnaire, laboratory experiment.

After 8 weeks(Visit 4), researchers check adverse effects and current medication status via telephone interview.

After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers check patients' physical examination, questionnaire, adverse effects and current medication status.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Placebo; Drug: WIN-34B

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 134-727
    • Kyung Hee University Oriental Medicine Hospital at Gangdong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Being between 35 and 80 years of age
2. Diagnosed with Osteoarthritis of the knee at least 3 months
3. Diagnosed with Osteoarthritis of the knee, based on ACR criteria
4. Able to communicate with researchers and write questionnaires
5. At the screening visit, checking 100mm Pain VAS at least 80mm
6. At randomization(Visit 2), checking 100mm Pain VAS over 50mm
7. Agreeing to participate and signing informed consent voluntarily

Exclusion Criteria:

1. Previous intra-articular injection on knee within 3 months
2. Previous knee surgery within 6 months or scheduled procedures
3. Other diseases that could affect or interfere with the therapeutic outcomes
4. Experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week
5. Diagnosed with gastrointestinal diseases, unable to stop medicines during the study
6. At the screening visit, identified liver dysfunction
7. At the screening visit, identified renal dysfunction
8. Patients who cannot take NSAIDs
9. Pregnancy and breast-feeding (women of childbearing age need pregnancy test)
10. Physicological or mental disorders, including drug-takers
11. Orthopedic diseases that could affect or interfere with the therapeutic outcomes
12. Inappropriate for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1st group : WIN-34B 900mg; Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks	Drug: WIN-34B; Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
Experimental: 2nd group : WIN-34B 1800mg; Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks	Drug: WIN-34B; Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
Placebo Comparator: 3rd group : Placebo; Patients assigned to 3rd group take Placebo BID for 12weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)	Changes from baseline at 4, 12, 16weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain VAS 100mm	Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
KHAQ(Korean Health Assessment Questionnaire)	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
LFI(Lequesne's Functional Index)	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Nine Point Scale	Visit5(12weeks)
Cold-Heat Questionnaire	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Dose and Frequency of Rescue drug	Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event)	Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Kyung Hee University Hospital at Gangdong; Hamsoa Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Dong-Suk Park, Kyung Hee University Hospital at Gangdong

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 20, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Osteoarthritis, Knee; WIN-34B
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KR-KHNMC-OA02