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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000732

Enrollment

150

Registered

2013-04-26

Start date

2013-05-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks Patients assigned to Comparator group(3rd group) take Placebo BID for 12weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Being between 35 and 80 years of age 2) Diagnosised with Osteoarthritis of the knee at least 3 months 3) Diagnosised with Osteoarthritis of the knee, based on ACR criteria 4) Able to communicate with researchers and write questionnaire 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

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) Diagnosised 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

Design outcomes

Primary

Measure	Time frame
KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)	—

Secondary

Measure	Time frame
Pain VAS 100mm;KHAQ(Korean Health Assessment Questionnaire) ;LFI(Lequesne's Functional Index) ;Nine Point Scale ;Cold-Heat Questionnaire;Dose and Frequency of Rescue drug;Satety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event Etc.)	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Kwan Seo

Kyung Hee University Oriental Medicine Hospital at Gangdong

Outcome results