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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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WIN-34B
Placebo
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, WIN-34B

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Oriental Medicine Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1st group : WIN-34B 900mg

2nd group : WIN-34B 1800mg

3rd group : Placebo

Arm Description

Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks

Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks

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

Outcomes

Primary Outcome Measures

KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2013
Last Updated
November 20, 2015
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, Hamsoa Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01873053
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, Hamsoa Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. st group (experimental) : WIN-34B 450mg BID nd group (experimental) : WIN-34B 900mg BID 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, WIN-34B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st group : WIN-34B 900mg
Arm Type
Experimental
Arm Description
Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks
Arm Title
2nd group : WIN-34B 1800mg
Arm Type
Experimental
Arm Description
Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
Arm Title
3rd group : Placebo
Arm Type
Placebo Comparator
Arm Description
Patients assigned to 3rd group take Placebo BID for 12weeks
Intervention Type
Drug
Intervention Name(s)
WIN-34B
Intervention Description
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame
Changes from baseline at 4, 12, 16weeks
Secondary Outcome Measure Information:
Title
Pain VAS 100mm
Time Frame
Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
Title
KHAQ(Korean Health Assessment Questionnaire)
Time Frame
Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Title
LFI(Lequesne's Functional Index)
Time Frame
Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Title
Nine Point Scale
Time Frame
Visit5(12weeks)
Title
Cold-Heat Questionnaire
Time Frame
Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks)
Title
Dose and Frequency of Rescue drug
Time Frame
Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Suk Park
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Oriental Medicine Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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