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Completed

NCT Number: NCT01756937

Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hallym Universicy Sacred heart Hospital, Anyang, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imotun

Drug

300.03mg/cap,orally, 1 capsule once daily for 24 weeks

Other names: Avocado-Soya Unsaponifiables 300.03mg/Cap

Placebo

Drug

1 capsule once daily for 24 weeks

Primary outcomes

  1. 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

  2. 100mm Pain VAS

    Time frame: 24 weeks

    assessment of 100mm Pain VAS (24weekS)

Secondary outcomes

  1. Change from baseline Lequesne's index score at 4weeks

    Time frame: baseline, 4 weeks

    Change from baseline Lequesne's index score at 4weeks

  2. Change from baseline Lequesne's index score at 8weeks

    Time frame: baseline, 8 weeks

    Change from baseline Lequesne's index score at 8weeks

  3. Change from baseline Lequesne's index score at 16weeks

    Time frame: baseline, 16 weeks

    Change from baseline Lequesne's index score at 16weeks

  4. 100mm Pain VAS

    Time frame: 4weeks

    • Patient's assessment of 100mm Pain VAS

  5. Global assement (Patient, Physician)

    Time frame: 4weeks

    -Global assement (Patient, Physician)

  6. administration days of the rescue medication

    Time frame: 24weeks

    administration days of the rescue medication

  7. The rate of patients who consumed the rescue medication

    Time frame: 24weeks

    The rate of patients who consumed the rescue medication

  8. 100mm Pain VAS

    Time frame: 8weeks

    • Patient's assessment of 100mm Pain VAS

  9. 100mm Pain VAS

    Time frame: 16weeks

    • Patient's assessment of 100mm Pain VAS

  10. change from baseline 100mm Pain VAS at 4weeeks

    Time frame: baseline, 4weeks

    change from baseline 100mm Pain VAS at 4weeeks

  11. change from baseline 100mm Pain VAS at 8weeeks

    Time frame: baseline, 8weeks

    change from baseline 100mm Pain VAS at 8weeeks

  12. change from baseline 100mm Pain VAS at 16weeeks

    Time frame: baseline, 16 weeks

    change from baseline 100mm Pain VAS at 16weeeks

  13. change from baseline 100mm Pain VAS at 24weeeks

    Time frame: baseline, 24 weeks

    change from baseline 100mm Pain VAS at 24weeeks

  14. Global assement (Patient, Physician)

    Time frame: 8weeks

    -Global assement (Patient, Physician)

  15. Global assement (Patient, Physician)

    Time frame: 16weeks

    -Global assement (Patient, Physician)

  16. change from baseline Global assement (Patient, Physician)

    Time frame: baseline, 16weeks

    -Global assement (Patient, Physician)

  17. Global assement (Patient, Physician)

    Time frame: 24weeks

    -Global assement (Patient, Physician)

  18. dosing quantity of the rescue medication

    Time frame: 24weeks

    dosing quantity of the rescue medication

Other outcomes

  1. Safety assessed by the incidence of adverse event

    Time frame: up to 24weeks

    Safety assessed by the incidence of adverse event

  2. laboratory test

    Time frame: up to 24weeks

    laboratory test

  3. medication history

    Time frame: up to 24weeks

    medication history

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: ABSOLUTE-R

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 28, 2012
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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