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NCT Number: NCT01873053

A 12 Week, 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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyung Hee University Oriental Medicine Hospital at Gangdong

Seoul, 134-727, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

WIN-34B

Drug

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

Placebo

Drug

Primary outcomes

  1. KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: Changes from baseline at 4, 12, 16weeks

Secondary outcomes

  1. Pain VAS 100mm

    Time frame: Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)

  2. KHAQ(Korean Health Assessment Questionnaire)

    Time frame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)

  3. LFI(Lequesne's Functional Index)

    Time frame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)

  4. Nine Point Scale

    Time frame: Visit5(12weeks)

  5. Cold-Heat Questionnaire

    Time frame: Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)

  6. Dose and Frequency of Rescue drug

    Time frame: Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)

  7. Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event)

    Time frame: Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Hamsoa Pharmaceutical Co., Ltd.
  • Kyung Hee University Hospital at Gangdong

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2013
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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