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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01756937
First received: October 30, 2012
Last updated: March 24, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    Change from baseline in the Lequesne's index score at 24weekS

  • 100mm Pain VAS [ Time Frame: 24 weeks ]
    assessment of 100mm Pain VAS (24weekS)


Secondary Outcome Measures:
  • Change from baseline Lequesne's index score at 4weeks [ Time Frame: baseline, 4 weeks ]
    Change from baseline Lequesne's index score at 4weeks

  • Change from baseline Lequesne's index score at 8weeks [ Time Frame: baseline, 8 weeks ]
    Change from baseline Lequesne's index score at 8weeks

  • Change from baseline Lequesne's index score at 16weeks [ Time Frame: baseline, 16 weeks ]
    Change from baseline Lequesne's index score at 16weeks

  • 100mm Pain VAS [ Time Frame: 4weeks ]
    - Patient's assessment of 100mm Pain VAS

  • Global assement (Patient, Physician) [ Time Frame: 4weeks ]
    -Global assement (Patient, Physician)

  • administration days of the rescue medication [ Time Frame: 24weeks ]
    administration days of the rescue medication

  • The rate of patients who consumed the rescue medication [ Time Frame: 24weeks ]
    The rate of patients who consumed the rescue medication

  • 100mm Pain VAS [ Time Frame: 8weeks ]
    - Patient's assessment of 100mm Pain VAS

  • 100mm Pain VAS [ Time Frame: 16weeks ]
    - Patient's assessment of 100mm Pain VAS

  • change from baseline 100mm Pain VAS at 4weeeks [ Time Frame: baseline, 4weeks ]
    change from baseline 100mm Pain VAS at 4weeeks

  • change from baseline 100mm Pain VAS at 8weeeks [ Time Frame: baseline, 8weeks ]
    change from baseline 100mm Pain VAS at 8weeeks

  • change from baseline 100mm Pain VAS at 16weeeks [ Time Frame: baseline, 16 weeks ]
    change from baseline 100mm Pain VAS at 16weeeks

  • change from baseline 100mm Pain VAS at 24weeeks [ Time Frame: baseline, 24 weeks ]
    change from baseline 100mm Pain VAS at 24weeeks

  • Global assement (Patient, Physician) [ Time Frame: 8weeks ]
    -Global assement (Patient, Physician)

  • Global assement (Patient, Physician) [ Time Frame: 16weeks ]
    -Global assement (Patient, Physician)

  • change from baseline Global assement (Patient, Physician) [ Time Frame: baseline, 16weeks ]
    -Global assement (Patient, Physician)

  • Global assement (Patient, Physician) [ Time Frame: 24weeks ]
    -Global assement (Patient, Physician)

  • dosing quantity of the rescue medication [ Time Frame: 24weeks ]
    dosing quantity of the rescue medication


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

  • laboratory test [ Time Frame: up to 24weeks ]
    laboratory test

  • medication history [ Time Frame: up to 24weeks ]
    medication history


Enrollment: 287
Study Start Date: January 2013
Study Completion Date: February 2017
Primary Completion Date: October 2016 (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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Korea, Republic of
Hallym Universicy Sacred heart Hospital
Anyang, Korea, Republic of, 431-070
Dong-A university Hospital
Busan, Korea, Republic of, 602-715
Yeungnam university medical center
Daegu, Korea, Republic of, 705-035
Chungnam National University hospital
Daejon, Korea, Republic of, 301-721
Chonnam National university medical school & Hospital
Gwangju, Korea, Republic of, 501-757
hanyang University Guri Hospital
Gyeonggi-do, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Chung-Ang University hospital
Seoul, Korea, Republic of, 156-755
Hanyang University Hospital
Special City of Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Dae Hyun Yoo Hanyang University
  More Information

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: March 24, 2017

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 August 18, 2017