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

This study is not yet open for participant recruitment.
Verified December 2012 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: January 3, 2013
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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
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
Hanyang University Hospital Not yet recruiting
Special City of Seoul, Korea, Republic of
Principal Investigator: Hyun Dae 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: January 3, 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 May 23, 2013