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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01743287
First received: December 3, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Imotun capsule
Drug: Imotun capsule placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • 100mm pain VAS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    assessment of the 100mm pain VAS

  • change from baseline Lequesne's index score at 24 weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline Lequesne's index score at 4 weeks [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline 100mm pain VAS at 4 weeks [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
  • 100mm pain VAS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    assessment of 100mm pain VAS

  • global assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    global assessment by physician and patient

  • administration days of the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The rate of patients who consumed the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline Lequesne's index score at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline Lequesne's index score at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline 100mm pain VAS at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline 100mm pain VAS at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline 100mm pain VAS at 24 weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
  • 100mm pain VAS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    assessment of 100mm pain VAS

  • 100mm pain VAS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    assessment of 100mm pain VAS

  • global assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    global assessment by physician and patient

  • global assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    global assessment by physician and patient

  • global assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    global assessment by physician and patient

  • dosing quantity of the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • rate of adverse event [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • laboratory test [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • medication history [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 234
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imotun capsule
Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks
Drug: Imotun capsule
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
Other Name: Imotun capsule
Placebo Comparator: Imotun capsule placebo
Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks
Drug: Imotun capsule placebo
Imotun capsule placebo: per oral, a capsule a day during 24 weeks

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743287

Contacts
Contact: Myung Chul Lee, phD +82 2 2072 3212 leemc@anu.ac.kr

Locations
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju, Chungcheonbuk-do, Korea, Republic of
Contact: Euisung Choi, Ph.D.    +82 43 269 6072    oseschoi@chungbuk.ac.kr   
Principal Investigator: Euisung Choi, Ph.D.         
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of, 633-165
Contact: Changwan Kim, Ph.D.    +82 51 890 6129    kcw8737@empal.com   
Principal Investigator: Changwan Kim, Ph.D.         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Heesoo Kyung, phD    +82 53 420 5636    hskyung@knu.ac.kr   
Principal Investigator: Heesoo Hyung, phD         
Chonnam National University Hwasun hospital Recruiting
Hwasun, Korea, Republic of, 519-763
Contact: Jeongkeun Seon, phD    +82 61 379 8030    seonbell@yahoo.co.kr   
Principal Investigator: Jeongkeun Seon, phD         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of, 561-712
Contact: Joohong Lee, phD    +82 63 250 1771    jhlee55@jbnu.ac.kr   
Principal Investigator: Joohong Lee, phD         
Bundang CHA medical center Recruiting
Seongnam, Korea, Republic of, 463-712
Contact: Heechun Kim, phD    +82 31 780 5270    khc4h@unitel.co.kr   
Principal Investigator: Heechun Kim, phD         
ASAN Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seongil Bin, phD    +82 2 3010 3528    sibin@amc.seoul.kr   
Principal Investigator: Seongil Bin, phD         
KyungHee University Medical Center Completed
Seoul, Korea, Republic of, 130-872
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Myungchul Lee, phD    +82 2 2072 3212    leemc@snu.ac.kr   
Principal Investigator: Myungchul Lee, phD         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Myung Chul Lee, phD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01743287     History of Changes
Other Study ID Numbers: 238KOA12F
Study First Received: December 3, 2012
Last Updated: July 23, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
osteoarthritis of the knee

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

ClinicalTrials.gov processed this record on November 20, 2014