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The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-OS)

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Imotun capsule
Imotun capsule placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis of the knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Chungbuk National University Hospital
  • Inje University Busan Paik Hospital
  • Kyungpook National University Hospital
  • Chonnam National University Hwasun hospital
  • Chonbuk National University Hospital
  • Bundang CHA medical center
  • Seoul National University Hospital
  • KyungHee University Medical Center
  • Samsung Medical Center
  • ASAN Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Imotun capsule

Imotun capsule placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

100mm pain VAS
assessment of the 100mm pain VAS
change from baseline Lequesne's index score at 24 weeks

Secondary Outcome Measures

change from baseline Lequesne's index score at 4 weeks
change from baseline 100mm pain VAS at 4 weeks
100mm pain VAS
assessment of 100mm pain VAS
global assessment
global assessment by physician and patient
administration days of the rescue medication
The rate of patients who consumed the rescue medication
change from baseline Lequesne's index score at 8 weeks
change from baseline Lequesne's index score at 16 weeks
change from baseline 100mm pain VAS at 8 weeks
change from baseline 100mm pain VAS at 16 weeks
change from baseline 100mm pain VAS at 24 weeks
100mm pain VAS
assessment of 100mm pain VAS
100mm pain VAS
assessment of 100mm pain VAS
global assessment
global assessment by physician and patient
global assessment
global assessment by physician and patient
global assessment
global assessment by physician and patient
dosing quantity of the rescue medication

Full Information

First Posted
December 3, 2012
Last Updated
April 29, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01743287
Brief Title
The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
Acronym
ABSOLUTE-OS
Official Title
A Six-month, Multi Center, Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
Detailed Description
This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis of the knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imotun capsule
Arm Type
Experimental
Arm Description
Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks
Arm Title
Imotun capsule placebo
Arm Type
Placebo Comparator
Arm Description
Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Imotun capsule
Intervention Description
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Imotun capsule placebo
Intervention Description
Imotun capsule placebo: per oral, a capsule a day during 24 weeks
Primary Outcome Measure Information:
Title
100mm pain VAS
Description
assessment of the 100mm pain VAS
Time Frame
24 weeks
Title
change from baseline Lequesne's index score at 24 weeks
Time Frame
baseline, 24 weeks
Secondary Outcome Measure Information:
Title
change from baseline Lequesne's index score at 4 weeks
Time Frame
baseline, 4 weeks
Title
change from baseline 100mm pain VAS at 4 weeks
Time Frame
baseline, 4 weeks
Title
100mm pain VAS
Description
assessment of 100mm pain VAS
Time Frame
4 weeks
Title
global assessment
Description
global assessment by physician and patient
Time Frame
4 weeks
Title
administration days of the rescue medication
Time Frame
24 weeks
Title
The rate of patients who consumed the rescue medication
Time Frame
24 weeks
Title
change from baseline Lequesne's index score at 8 weeks
Time Frame
baseline, 8 weeks
Title
change from baseline Lequesne's index score at 16 weeks
Time Frame
baseline, 16 weeks
Title
change from baseline 100mm pain VAS at 8 weeks
Time Frame
baseline, 8 weeks
Title
change from baseline 100mm pain VAS at 16 weeks
Time Frame
baseline, 16 weeks
Title
change from baseline 100mm pain VAS at 24 weeks
Time Frame
baseline, 24 weeks
Title
100mm pain VAS
Description
assessment of 100mm pain VAS
Time Frame
8 weeks
Title
100mm pain VAS
Description
assessment of 100mm pain VAS
Time Frame
16 weeks
Title
global assessment
Description
global assessment by physician and patient
Time Frame
8 weeks
Title
global assessment
Description
global assessment by physician and patient
Time Frame
16 weeks
Title
global assessment
Description
global assessment by physician and patient
Time Frame
24 weeks
Title
dosing quantity of the rescue medication
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
rate of adverse event
Time Frame
up to 24 weeks
Title
laboratory test
Time Frame
up to 24 weeks
Title
medication history
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Chul Lee, phD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
State/Province
Chungcheonbuk-do
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
633-165
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun hospital
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Bundang CHA medical center
City
Seongnam
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

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