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

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ClinicalTrials.gov Identifier: NCT01873053
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : November 24, 2015
Sponsor:
Collaborators:
Kyung Hee University Hospital at Gangdong
Hamsoa Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Park Dong-Suk, 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: WIN-34B Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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

Experimental: 2nd group : WIN-34B 1800mg
Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
Drug: WIN-34B
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks

Placebo Comparator: 3rd group : Placebo
Patients assigned to 3rd group take Placebo BID for 12weeks
Drug: Placebo



Primary Outcome Measures :
  1. KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: Changes from baseline at 4, 12, 16weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873053


Locations
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Korea, Republic of
Kyung Hee University Oriental Medicine Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Hamsoa Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Dong-Suk Park Kyung Hee University Hospital at Gangdong

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Responsible Party: Park Dong-Suk, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01873053     History of Changes
Other Study ID Numbers: KR-KHNMC-OA02
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015

Keywords provided by Park Dong-Suk, Kyunghee University Medical Center:
Osteoarthritis, Knee
WIN-34B

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases