Osteoarthritis of the KneePhase 4ABSOLUTE-RNCT01756937
Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
A Phase 4 study testing Imotun in people with Osteoarthritis of the Knee, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.
Trial summary
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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jan 2013to Feb 2017
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Hallym Universicy Sacred heart Hospital
Anyang, 431-070
Dong-A university Hospital
Busan, 602-715
Yeungnam university medical center
Daegu, 705-035
Chungnam National University hospital
Daejeon, 301-721
Chonnam National university medical school & Hospital
Gwangju, 501-757
hanyang University Guri Hospital
Gyeonggi-do
Konkuk University Medical Center
Seoul, 143-729
Chung-Ang University hospital
Seoul, 156-755
Hanyang University Hospital
Special City of Seoul
About this study
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
Efficacy and safety of Imotun capsule in osteoarthritis of the knee
Read the 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
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Imotun, 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.
ImotunDrug
Also called Avocado-Soya Unsaponifiables 300.03mg/Cap
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
PlaceboDrug
1 capsule once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imotun | Active comparator | 300.03mg/cap,orally, 1 capsule once daily for 24 weeks Receives: Drug: Imotun |
| Placebo | Placebo comparator | 1 capsule once daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Lequesne's index score at 24weeks
Change from baseline in the Lequesne's index score at 24weekS
Measured: baseline, 24 weeks
100mm Pain VAS
assessment of 100mm Pain VAS (24weekS)
Measured: 24 weeks
Secondary outcomes (18)
Change from baseline Lequesne's index score at 4weeks
Change from baseline Lequesne's index score at 4weeks
Measured: baseline, 4 weeks
Change from baseline Lequesne's index score at 8weeks
Change from baseline Lequesne's index score at 8weeks
Measured: baseline, 8 weeks
Change from baseline Lequesne's index score at 16weeks
Change from baseline Lequesne's index score at 16weeks
Measured: baseline, 16 weeks
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
Measured: 4weeks
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Measured: 4weeks
administration days of the rescue medication
administration days of the rescue medication
Measured: 24weeks
The rate of patients who consumed the rescue medication
The rate of patients who consumed the rescue medication
Measured: 24weeks
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
Measured: 8weeks
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
Measured: 16weeks
change from baseline 100mm Pain VAS at 4weeeks
change from baseline 100mm Pain VAS at 4weeeks
Measured: baseline, 4weeks
change from baseline 100mm Pain VAS at 8weeeks
change from baseline 100mm Pain VAS at 8weeeks
Measured: baseline, 8weeks
change from baseline 100mm Pain VAS at 16weeeks
change from baseline 100mm Pain VAS at 16weeeks
Measured: baseline, 16 weeks
change from baseline 100mm Pain VAS at 24weeeks
change from baseline 100mm Pain VAS at 24weeeks
Measured: baseline, 24 weeks
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Measured: 8weeks
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Measured: 16weeks
change from baseline Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Measured: baseline, 16weeks
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Measured: 24weeks
dosing quantity of the rescue medication
dosing quantity of the rescue medication
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionFeb 2017
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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae Hyun Yoo, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756937
- Sponsor's protocol ID
- 238KOA12G
- Acronym
- ABSOLUTE-R
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01756937
- Acronym / sponsor ID
- ABSOLUTE-R / 238KOA12G
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis of the knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 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.
Efficacy and safety of Imotun capsule in osteoarthritis of the knee
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 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 | Active comparator | Drug: Imotun300.03mg/cap,orally, 1 capsule once daily for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo1 capsule once daily for 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)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| ImotunAlso: Avocado-Soya Unsaponifiables 300.03mg/Cap300.03mg/cap,orally, 1 capsule once daily for 24 weeks | Drug | Imotun |
| Placebo1 capsule once daily for 24 weeks | Drug | Placebo |
Primary outcome
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)
18 secondary outcomes
Change from baseline Lequesne's index score at 4weeks
Time frame: 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 16weeks
Time frame: baseline, 16 weeks
100mm Pain VAS
Time frame: 4weeks
Global assement (Patient, Physician)
Time frame: 4weeks
administration days of the rescue medication
Time frame: 24weeks
The rate of patients who consumed the rescue medication
Time frame: 24weeks
100mm Pain VAS
Time frame: 8weeks
100mm Pain VAS
Time frame: 16weeks
change from baseline 100mm Pain VAS at 4weeeks
Time frame: baseline, 4weeks
change from baseline 100mm Pain VAS at 8weeeks
Time frame: baseline, 8weeks
change from baseline 100mm Pain VAS at 16weeeks
Time frame: baseline, 16 weeks
change from baseline 100mm Pain VAS at 24weeeks
Time frame: baseline, 24 weeks
Global assement (Patient, Physician)
Time frame: 8weeks
Global assement (Patient, Physician)
Time frame: 16weeks
change from baseline Global assement (Patient, Physician)
Time frame: baseline, 16weeks
Global assement (Patient, Physician)
Time frame: 24weeks
dosing quantity of the rescue medication
Time frame: 24weeks
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 27 Mar 2017.
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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.
Dae Hyun Yoo principal investigator
Hanyang University
9 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 in people with Osteoarthritis of the Knee, run by Chong Kun Dang Pharmaceutical at 9 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Change from baseline in the Lequesne's index score at 24weeks (time frame: baseline, 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 27 Mar 2017.