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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873053
• Other study ID #: KR-KHNMC-OA02
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2013
• Last updated: November 20, 2015
• Start date: April 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• WIN-34B
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Oriental Medicine Hospital at Gangdong	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Hamsoa Pharmaceutical Co., Ltd., Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)		Changes from baseline at 4, 12, 16weeks	No
Secondary	Pain VAS 100mm		Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)	No
Secondary	KHAQ(Korean Health Assessment Questionnaire)		Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)	No
Secondary	LFI(Lequesne's Functional Index)		Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)	No
Secondary	Nine Point Scale		Visit5(12weeks)	No
Secondary	Cold-Heat Questionnaire		Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)	No
Secondary	Dose and Frequency of Rescue drug		Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)	No
Secondary	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	Yes