The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-OS)
This study is currently recruiting participants.
Verified January 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01743287
First received: December 3, 2012
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Knee |
Drug: Imotun capsule Drug: Imotun capsule placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chong Kun Dang Pharmaceutical:
Primary Outcome Measures:
- 100mm pain VAS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]assessment of the 100mm pain VAS
- change from baseline Lequesne's index score at 24 weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change from baseline Lequesne's index score at 4 weeks [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
- change from baseline 100mm pain VAS at 4 weeks [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
- 100mm pain VAS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]assessment of 100mm pain VAS
- global assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]global assessment by physician and patient
- administration days of the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The rate of patients who consumed the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- change from baseline Lequesne's index score at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
- change from baseline Lequesne's index score at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
- change from baseline 100mm pain VAS at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
- change from baseline 100mm pain VAS at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
- change from baseline 100mm pain VAS at 24 weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
- 100mm pain VAS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]assessment of 100mm pain VAS
- 100mm pain VAS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]assessment of 100mm pain VAS
- global assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]global assessment by physician and patient
- global assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]global assessment by physician and patient
- global assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]global assessment by physician and patient
- dosing quantity of the rescue medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- rate of adverse event [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
- laboratory test [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
- medication history [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 234 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Imotun capsule
Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks
|
Drug: Imotun capsule
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
Other Name: Imotun capsule
|
|
Placebo Comparator: Imotun capsule placebo
Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks
|
Drug: Imotun capsule placebo
Imotun capsule placebo: per oral, a capsule a day during 24 weeks
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Patients with Lequesne's index 5 or more on screening and baseline visit
Exclusion Criteria:
- 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
- Patients who were treated with joint space injection within the past 3 months
- Patients who had taken NSAIDs 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743287
Contacts
| Contact: Myung Chul Lee, phD | +82 2 2072 3212 | leemc@anu.ac.kr |
Locations
| Korea, Republic of | |
| Kyungpook National University Hospital | Not yet recruiting |
| Daegu, Korea, Republic of, 700-721 | |
| Contact: Heesoo Kyung, phD +82 53 420 5636 hskyung@knu.ac.kr | |
| Principal Investigator: Heesoo Hyung, phD | |
| Chonnam National University Hwasun hospital | Not yet recruiting |
| Hwasun, Korea, Republic of, 519-763 | |
| Contact: Jeongkeun Seon, phD +82 61 379 8030 seonbell@yahoo.co.kr | |
| Principal Investigator: Jeongkeun Seon, phD | |
| Chonbuk National University Hospital | Not yet recruiting |
| Jeonju, Korea, Republic of, 561-712 | |
| Contact: Joohong Lee, phD +82 63 250 1771 jhlee55@jbnu.ac.kr | |
| Principal Investigator: Joohong Lee, phD | |
| Bundang CHA medical center | Not yet recruiting |
| Seongnam, Korea, Republic of, 463-712 | |
| Contact: Heechun Kim, phD +82 31 780 5270 khc4h@unitel.co.kr | |
| Principal Investigator: Heechun Kim, phD | |
| KyungHee University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 130-872 | |
| Contact: Kyoungho Yoon, phD kyoungho@khmc.or.kr | |
| Principal Investigator: Kyoungho Yoon, phD | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Myungchul Lee, phD +82 2 2072 3212 leemc@snu.ac.kr | |
| Principal Investigator: Myungchul Lee, phD | |
| ASAN Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Seongil Bin, phD +82 2 3010 3528 sibin@amc.seoul.kr | |
| Principal Investigator: Seongil Bin, phD | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Youngwan Moon, phD +82 2 3410 3509 ywmoon@skku.edu | |
| Principal Investigator: Youngwan Moon, phD | |
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
| Principal Investigator: | Myung Chul Lee, phD | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Chong Kun Dang Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT01743287 History of Changes |
| Other Study ID Numbers: | 238KOA12F |
| Study First Received: | December 3, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Chong Kun Dang Pharmaceutical:
|
osteoarthritis of the knee |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013