NCT01743287

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

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

December 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 30, 2015

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

December 3, 2012

Last Update Submit

April 29, 2015

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee

Outcome Measures

Primary Outcomes (2)

  • 100mm pain VAS

    assessment of the 100mm pain VAS

    24 weeks

  • change from baseline Lequesne's index score at 24 weeks

    baseline, 24 weeks

Secondary Outcomes (17)

  • change from baseline Lequesne's index score at 4 weeks

    baseline, 4 weeks

  • change from baseline 100mm pain VAS at 4 weeks

    baseline, 4 weeks

  • 100mm pain VAS

    4 weeks

  • global assessment

    4 weeks

  • administration days of the rescue medication

    24 weeks

  • +12 more secondary outcomes

Other Outcomes (3)

  • rate of adverse event

    up to 24 weeks

  • laboratory test

    up to 24 weeks

  • medication history

    up to 24 weeks

Study Arms (2)

Imotun capsule

EXPERIMENTAL

Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks

Drug: Imotun capsule

Imotun capsule placebo

PLACEBO COMPARATOR

Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks

Drug: Imotun capsule placebo

Interventions

Imotun capsuleDRUG

Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks

Imotun capsule
Imotun capsule placeboDRUG

Imotun capsule placebo: per oral, a capsule a day during 24 weeks

Imotun capsule placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male patients who aged 40 or more and agreement with written informed consent
  • Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more
  • Patients with Kellgren \& Lawrence grade Ⅱ\~Ⅲ on radiographs
  • Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)
  • Patients with Lequesne's index 5 or more on screening and baseline visit

You may not qualify if:

  • Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)
  • Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)
  • Patients who were treated with joint space injection within the past 3 months
  • Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)
  • Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.
  • Patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator
  • Patients with active peptic ulcer or GI bleeding.
  • Pregnancy, nursing women or women of reproductive age who do not agree to the contraception.
  • Patients with abuse of alcohol, illegal drugs or drug dependency
  • Patients who were treated with another investigational product within the past 4 weeks
  • All other patients who are not acceptable for the study determined by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chungbuk National University Hospital

Cheongju-si, Chungcheonbuk-do, South Korea

Location

Inje University Busan Paik Hospital

Busan, 633-165, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Chonnam National University Hwasun hospital

Hwasun, 519-763, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Bundang CHA medical center

Seongnam, 463-712, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

KyungHee University Medical Center

Seoul, 130-872, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

ASAN Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Myung Chul Lee, phD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 6, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 30, 2015

Record last verified: 2014-07

Locations

KR(10)