Osteoarthritis of the KneePhase 4ABSOLUTE-OSNCT01743287
The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
A Phase 4 study testing Imotun capsule in people with Osteoarthritis of the Knee, run by Chong Kun Dang Pharmaceutical at 10 sites in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Imotun capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Dec 2012to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients who aged 40 or more and agreement with written informed consent
- Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more
- Patients with Kellgren \& Lawrence grade Ⅱ~Ⅲ on radiographs
- Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)
- Patients with Lequesne's index 5 or more on screening and baseline visit
Who cannot join
- Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)
- Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)
- Patients who were treated with joint space injection within the past 3 months
- Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)
- Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.
- Patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator
Show all 11Show fewer
- Patients with active peptic ulcer or GI bleeding.
- Pregnancy, nursing women or women of reproductive age who do not agree to the contraception.
- Patients with abuse of alcohol, illegal drugs or drug dependency
- Patients who were treated with another investigational product within the past 4 weeks
- All other patients who are not acceptable for the study determined by investigator
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Inje University Busan Paik Hospital
Busan, 633-165
Chungbuk National University Hospital
Cheongju-si, Chungcheonbuk-do
Kyungpook National University Hospital
Daegu, 700-721
Chonnam National University Hwasun hospital
Hwasun, 519-763
Chonbuk National University Hospital
Jeonju, 561-712
Bundang CHA medical center
Seongnam, 463-712
Seoul National University Hospital
Seoul, 110-744
KyungHee University Medical Center
Seoul, 130-872
Samsung Medical Center
Seoul, 135-710
ASAN Medical Center
Seoul, 138-736
About this study
Official title: A Six-month, Multi Center, Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
Read the detailed description
This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Imotun capsule, Imotun capsule placebo
- Keywords
- osteoarthritis of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imotun capsuleDrug
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
Imotun capsule placeboDrug
Imotun capsule placebo: per oral, a capsule a day during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imotun capsule | Experimental | Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks Receives: Drug: Imotun capsule |
| Imotun capsule placebo | Placebo comparator | Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks Receives: Drug: Imotun capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm pain VAS
assessment of the 100mm pain VAS
Measured: 24 weeks
change from baseline Lequesne's index score at 24 weeks
Measured: baseline, 24 weeks
Secondary outcomes (17)
change from baseline Lequesne's index score at 4 weeks
Measured: baseline, 4 weeks
change from baseline 100mm pain VAS at 4 weeks
Measured: baseline, 4 weeks
100mm pain VAS
assessment of 100mm pain VAS
Measured: 4 weeks
global assessment
global assessment by physician and patient
Measured: 4 weeks
administration days of the rescue medication
Measured: 24 weeks
The rate of patients who consumed the rescue medication
Measured: 24 weeks
change from baseline Lequesne's index score at 8 weeks
Measured: baseline, 8 weeks
change from baseline Lequesne's index score at 16 weeks
Measured: baseline, 16 weeks
change from baseline 100mm pain VAS at 8 weeks
Measured: baseline, 8 weeks
change from baseline 100mm pain VAS at 16 weeks
Measured: baseline, 16 weeks
change from baseline 100mm pain VAS at 24 weeks
Measured: baseline, 24 weeks
100mm pain VAS
assessment of 100mm pain VAS
Measured: 8 weeks
100mm pain VAS
assessment of 100mm pain VAS
Measured: 16 weeks
global assessment
global assessment by physician and patient
Measured: 8 weeks
global assessment
global assessment by physician and patient
Measured: 16 weeks
global assessment
global assessment by physician and patient
Measured: 24 weeks
dosing quantity of the rescue medication
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Chul Lee, phD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743287
- Sponsor's protocol ID
- 238KOA12F
- Acronym
- ABSOLUTE-OS
- Status last verified
- Jul 2014
- First submitted
- 3 Dec 2012
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month, Multi Center, Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01743287
- Acronym / sponsor ID
- ABSOLUTE-OS / 238KOA12F
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis of the knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
Detailed description
This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imotun capsule | Experimental | Drug: Imotun capsuleImotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks |
| Imotun capsule placebo | Placebo comparator | Drug: Imotun capsule placeboImotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male patients who aged 40 or more and agreement with written informed consent
- Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more
- Patients with Kellgren \& Lawrence grade Ⅱ~Ⅲ on radiographs
- Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)
- Patients with Lequesne's index 5 or more on screening and baseline visit
Key exclusion criteria (11 listed)
- Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)
- Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)
- Patients who were treated with joint space injection within the past 3 months
- Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)
- Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imotun capsuleImotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks | Drug | Imotun capsule |
| Imotun capsule placeboImotun capsule placebo: per oral, a capsule a day during 24 weeks | Drug | Imotun capsule placebo |
Primary outcome
100mm pain VAS
Time frame: 24 weeks
assessment of the 100mm pain VAS
change from baseline Lequesne's index score at 24 weeks
Time frame: baseline, 24 weeks
17 secondary outcomes
change from baseline Lequesne's index score at 4 weeks
Time frame: baseline, 4 weeks
change from baseline 100mm pain VAS at 4 weeks
Time frame: baseline, 4 weeks
100mm pain VAS
Time frame: 4 weeks
global assessment
Time frame: 4 weeks
administration days of the rescue medication
Time frame: 24 weeks
The rate of patients who consumed the rescue medication
Time frame: 24 weeks
change from baseline Lequesne's index score at 8 weeks
Time frame: baseline, 8 weeks
change from baseline Lequesne's index score at 16 weeks
Time frame: baseline, 16 weeks
change from baseline 100mm pain VAS at 8 weeks
Time frame: baseline, 8 weeks
change from baseline 100mm pain VAS at 16 weeks
Time frame: baseline, 16 weeks
change from baseline 100mm pain VAS at 24 weeks
Time frame: baseline, 24 weeks
100mm pain VAS
Time frame: 8 weeks
100mm pain VAS
Time frame: 16 weeks
global assessment
Time frame: 8 weeks
global assessment
Time frame: 16 weeks
global assessment
Time frame: 24 weeks
dosing quantity of the rescue medication
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Chul Lee, phD principal investigator
Seoul National University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imotun capsule in people with Osteoarthritis of the Knee, run by Chong Kun Dang Pharmaceutical at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm pain VAS (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.