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

March 24, 2017 updated by: Chong Kun Dang Pharmaceutical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, 24 weeks
100mm Pain VAS
Time Frame: 24 weeks
assessment of 100mm Pain VAS (24weekS)
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Lequesne's index score at 4weeks
Time Frame: baseline, 4 weeks
Change from baseline Lequesne's index score at 4weeks
baseline, 4 weeks
Change from baseline Lequesne's index score at 8weeks
Time Frame: baseline, 8 weeks
Change from baseline Lequesne's index score at 8weeks
baseline, 8 weeks
Change from baseline Lequesne's index score at 16weeks
Time Frame: baseline, 16 weeks
Change from baseline Lequesne's index score at 16weeks
baseline, 16 weeks
100mm Pain VAS
Time Frame: 4weeks
- Patient's assessment of 100mm Pain VAS
4weeks
Global assement (Patient, Physician)
Time Frame: 4weeks
-Global assement (Patient, Physician)
4weeks
administration days of the rescue medication
Time Frame: 24weeks
administration days of the rescue medication
24weeks
The rate of patients who consumed the rescue medication
Time Frame: 24weeks
The rate of patients who consumed the rescue medication
24weeks
100mm Pain VAS
Time Frame: 8weeks
- Patient's assessment of 100mm Pain VAS
8weeks
100mm Pain VAS
Time Frame: 16weeks
- Patient's assessment of 100mm Pain VAS
16weeks
change from baseline 100mm Pain VAS at 4weeeks
Time Frame: baseline, 4weeks
change from baseline 100mm Pain VAS at 4weeeks
baseline, 4weeks
change from baseline 100mm Pain VAS at 8weeeks
Time Frame: baseline, 8weeks
change from baseline 100mm Pain VAS at 8weeeks
baseline, 8weeks
change from baseline 100mm Pain VAS at 16weeeks
Time Frame: baseline, 16 weeks
change from baseline 100mm Pain VAS at 16weeeks
baseline, 16 weeks
change from baseline 100mm Pain VAS at 24weeeks
Time Frame: baseline, 24 weeks
change from baseline 100mm Pain VAS at 24weeeks
baseline, 24 weeks
Global assement (Patient, Physician)
Time Frame: 8weeks
-Global assement (Patient, Physician)
8weeks
Global assement (Patient, Physician)
Time Frame: 16weeks
-Global assement (Patient, Physician)
16weeks
change from baseline Global assement (Patient, Physician)
Time Frame: baseline, 16weeks
-Global assement (Patient, Physician)
baseline, 16weeks
Global assement (Patient, Physician)
Time Frame: 24weeks
-Global assement (Patient, Physician)
24weeks
dosing quantity of the rescue medication
Time Frame: 24weeks
dosing quantity of the rescue medication
24weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety assessed by the incidence of adverse event
Time Frame: up to 24weeks
Safety assessed by the incidence of adverse event
up to 24weeks
laboratory test
Time Frame: up to 24weeks
laboratory test
up to 24weeks
medication history
Time Frame: up to 24weeks
medication history
up to 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 238KOA12G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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