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

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

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Imotun; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of, 431-070
    • Hallym Universicy Sacred heart Hospital
  • Busan, Korea, Republic of, 602-715
    • Dong-A University Hospital
  • Daegu, Korea, Republic of, 705-035
    • Yeungnam University Medical Center
  • Daejon, Korea, Republic of, 301-721
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National university medical school & Hospital
  • Gyeonggi-do, Korea, Republic of
    • Hanyang University GURI Hospital
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Special City of Seoul, Korea, Republic of
    • Hanyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Lequesne's index score at 24weeks	Change from baseline in the Lequesne's index score at 24weekS	baseline, 24 weeks
100mm Pain VAS	assessment of 100mm Pain VAS (24weekS)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Lequesne's index score at 4weeks	Change from baseline Lequesne's index score at 4weeks	baseline, 4 weeks
Change from baseline Lequesne's index score at 8weeks	Change from baseline Lequesne's index score at 8weeks	baseline, 8 weeks
Change from baseline Lequesne's index score at 16weeks	Change from baseline Lequesne's index score at 16weeks	baseline, 16 weeks
100mm Pain VAS	- Patient's assessment of 100mm Pain VAS	4weeks
Global assement (Patient, Physician)	-Global assement (Patient, Physician)	4weeks
administration days of the rescue medication	administration days of the rescue medication	24weeks
The rate of patients who consumed the rescue medication	The rate of patients who consumed the rescue medication	24weeks
100mm Pain VAS	- Patient's assessment of 100mm Pain VAS	8weeks
100mm Pain VAS	- Patient's assessment of 100mm Pain VAS	16weeks
change from baseline 100mm Pain VAS at 4weeeks	change from baseline 100mm Pain VAS at 4weeeks	baseline, 4weeks
change from baseline 100mm Pain VAS at 8weeeks	change from baseline 100mm Pain VAS at 8weeeks	baseline, 8weeks
change from baseline 100mm Pain VAS at 16weeeks	change from baseline 100mm Pain VAS at 16weeeks	baseline, 16 weeks
change from baseline 100mm Pain VAS at 24weeeks	change from baseline 100mm Pain VAS at 24weeeks	baseline, 24 weeks
Global assement (Patient, Physician)	-Global assement (Patient, Physician)	8weeks
Global assement (Patient, Physician)	-Global assement (Patient, Physician)	16weeks
change from baseline Global assement (Patient, Physician)	-Global assement (Patient, Physician)	baseline, 16weeks
Global assement (Patient, Physician)	-Global assement (Patient, Physician)	24weeks
dosing quantity of the rescue medication	dosing quantity of the rescue medication	24weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by the incidence of adverse event	Safety assessed by the incidence of adverse event	up to 24weeks
laboratory test	laboratory test	up to 24weeks
medication history	medication history	up to 24weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (ESTIMATE): December 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: osteoarthritis of the knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 238KOA12G