NCT01873053

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. 1.st group (experimental) : WIN-34B 450mg BID
  2. 2.nd group (experimental) : WIN-34B 900mg BID
  3. 3.rd group (Comparator) : Placebo BID

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

May 22, 2013

Last Update Submit

November 20, 2015

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, KneeWIN-34B

Outcome Measures

Primary Outcomes (1)

  • KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)

    Changes from baseline at 4, 12, 16weeks

Secondary Outcomes (7)

  • Pain VAS 100mm

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

  • KHAQ(Korean Health Assessment Questionnaire)

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

  • LFI(Lequesne's Functional Index)

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

  • Nine Point Scale

    Visit5(12weeks)

  • Cold-Heat Questionnaire

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

  • +2 more secondary outcomes

Study Arms (3)

1st group : WIN-34B 900mg

EXPERIMENTAL

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

Drug: WIN-34B

2nd group : WIN-34B 1800mg

EXPERIMENTAL

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

Drug: WIN-34B

3rd group : Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

WIN-34BDRUG

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

1st group : WIN-34B 900mg2nd group : WIN-34B 1800mg
PlaceboDRUG
3rd group : Placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Oriental Medicine Hospital at Gangdong

Seoul, 134-727, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

WIN 34B

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dong-Suk Park

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2013

First Posted

June 7, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

KR(1)