Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01756937
First received: October 30, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

Efficacy and safety of Imotun capsule in osteoarthritis of the knee


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Imotun
Drug: 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, Randomizied, 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:
  • Change from baseline in the Lequesne's index score at 24weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Lequesne's index score at 24weekS

  • 100mm Pain VAS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    assessment of 100mm Pain VAS (24weekS)


Secondary Outcome Measures:
  • Change from baseline Lequesne's index score at 4weeks [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline Lequesne's index score at 4weeks

  • Change from baseline Lequesne's index score at 8weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline Lequesne's index score at 8weeks

  • Change from baseline Lequesne's index score at 16weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline Lequesne's index score at 16weeks

  • 100mm Pain VAS [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    - Patient's assessment of 100mm Pain VAS

  • Global assement (Patient, Physician) [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    -Global assement (Patient, Physician)

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

  • The rate of patients who consumed the rescue medication [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    The rate of patients who consumed the rescue medication

  • 100mm Pain VAS [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
    - Patient's assessment of 100mm Pain VAS

  • 100mm Pain VAS [ Time Frame: 16weeks ] [ Designated as safety issue: No ]
    - Patient's assessment of 100mm Pain VAS

  • change from baseline 100mm Pain VAS at 4weeeks [ Time Frame: baseline, 4weeks ] [ Designated as safety issue: No ]
    change from baseline 100mm Pain VAS at 4weeeks

  • change from baseline 100mm Pain VAS at 8weeeks [ Time Frame: baseline, 8weeks ] [ Designated as safety issue: No ]
    change from baseline 100mm Pain VAS at 8weeeks

  • change from baseline 100mm Pain VAS at 16weeeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    change from baseline 100mm Pain VAS at 16weeeks

  • change from baseline 100mm Pain VAS at 24weeeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
    change from baseline 100mm Pain VAS at 24weeeks

  • Global assement (Patient, Physician) [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
    -Global assement (Patient, Physician)

  • Global assement (Patient, Physician) [ Time Frame: 16weeks ] [ Designated as safety issue: No ]
    -Global assement (Patient, Physician)

  • change from baseline Global assement (Patient, Physician) [ Time Frame: baseline, 16weeks ] [ Designated as safety issue: No ]
    -Global assement (Patient, Physician)

  • Global assement (Patient, Physician) [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    -Global assement (Patient, Physician)

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


Other Outcome Measures:
  • Safety assessed by the incidence of adverse event [ Time Frame: up to 24weeks ] [ Designated as safety issue: Yes ]
    Safety assessed by the incidence of adverse event

  • laboratory test [ Time Frame: up to 24weeks ] [ Designated as safety issue: Yes ]
    laboratory test

  • medication history [ Time Frame: up to 24weeks ] [ Designated as safety issue: Yes ]
    medication history


Estimated Enrollment: 324
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Drug: Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Other Name: Avocado-Soya Unsaponifiables 300.03mg/Cap
Placebo Comparator: Placebo
1 capsule once daily for 24 weeks
Drug: Placebo
1 capsule once daily for 24 weeks
Other Name: placebo

Detailed Description:

A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Agreement with written informed consent and 40 years of age and older
  • Patients with more than 63months history of OA of knee according to ACR criteria
  • Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee
  • The 100mm Pain VAS is over 40mm
  • The Lequensne's index is over 5

Exclusion Criteria:

  • Treatment with SYSADOA within 3 months
  • History of joint surgery within 5 years or Arthroscopic surgery within 1year
  • Intra-articular injections within 3 months
  • Treatment with NASIDs within 7 days
  • Any history of adverse reaction to the study drugs
  • clinically significant hepatic, renal, cardiovascular diseases
  • Patients with gastrointestinal ulcers or bleeding disorders
  • Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
  • History of drug abuse or alcoholism
  • Patients on any other clinical trial or experimental treatment in the past 4 weeks
  • An impossible one who participates in clinical trial by investigator's decision
  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: NCT01756937

Contacts
Contact: Dae Hyun Yoo 82-2-2290-9202 dhyoo@hanyang.ac.kr

Locations
Korea, Republic of
Hallym Universicy Sacred heart Hospital Recruiting
Anyang, Korea, Republic of, 431-070
Contact: Hyun Ah Kim, PhD    82-31-380-1826    baladeur@hallym.or.kr   
Principal Investigator: Hyun Ah Kim, PhD         
Dong-A university Hospital Active, not recruiting
Busan, Korea, Republic of, 602-715
Yeungnam university medical center Recruiting
Daegu, Korea, Republic of, 705-035
Contact: Choongki Lee, PhD    82-53-620-3841    cklee@med.yu.ac.kr   
Principal Investigator: Choongko Lee, PhD         
Chungnam National University hospital Active, not recruiting
Daejon, Korea, Republic of, 301-721
Chonnam National university medical school & Hospital Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Shin Seok Lee, PhD    82-62-220-6590    shinseok@chonnam.ac.kr   
Principal Investigator: Shin Seok Lee, PhD         
Ajuo university hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 433-721
hanyang University Guri Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Hye Soon Lee, PhD    82-31-560-2247    lhsberon@hanyang.ac.kr   
Principal Investigator: Hye Soon Lee, PhD         
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: SangHeon Lee, PhD    82-2-2030-7541    shlee@kuh.ac.kr   
Principal Investigator: SangHeon Lee, PhD         
Chung-Ang University hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Jung Soo Song, PhD    82-2-6299-1409    drsong@cau.ac.kr   
Principal Investigator: Jung Soo Song, PhD         
Hanyang University Hospital Recruiting
Special City of Seoul, Korea, Republic of
Contact: Daehyun Yoo, phD         
Principal Investigator: DaeHyun Yoo         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Dae Hyun Yoo Hanyang University
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01756937     History of Changes
Other Study ID Numbers: 238KOA12G
Study First Received: October 30, 2012
Last Updated: September 25, 2013
Health Authority: 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 October 23, 2014