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

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: WIN-34B; Drug: Placebo

• Registration Number: NCT01873053
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2nd group : WIN-34B 1800mg	WIN-34B	Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
3rd group : Placebo	Placebo	Patients assigned to 3rd group take Placebo BID for 12weeks
1st group : WIN-34B 900mg	WIN-34B	Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Pain VAS 100mm	Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
LFI(Lequesne's Functional Index)	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Dose and Frequency of Rescue drug	Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
KHAQ(Korean Health Assessment Questionnaire)	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Cold-Heat Questionnaire	Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Nine Point Scale	Visit5(12weeks)

Trial Locations

Locations (1)

Kyung Hee University Oriental Medicine Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of