Clinical trial NCT01873053: A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
WIN-34B
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: Hamsoa Pharmaceutical Co., Ltd.
First posted: 2013-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: Changes from baseline at 4, 12, 16weeks
Secondary outcomes:
measure: Pain VAS 100mm
timeFrame: Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
measure: KHAQ(Korean Health Assessment Questionnaire)
timeFrame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
measure: LFI(Lequesne's Functional Index)
timeFrame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
measure: Nine Point Scale
timeFrame: Visit5(12weeks)
measure: Cold-Heat Questionnaire
timeFrame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
measure: Dose and Frequency of Rescue drug
timeFrame: Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
measure: Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event)
timeFrame: Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Oriental Medicine Hospital at Gangdong
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Dong-Suk Park
role: PRINCIPAL_INVESTIGATOR
References: