Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
NCT ID: NCT01756937
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
287 participants
INTERVENTIONAL
2013-01-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Placebo
1 capsule once daily for 24 weeks
Placebo
1 capsule once daily for 24 weeks
Interventions
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Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Placebo
1 capsule once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Dae Hyun Yoo
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
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Hallym Universicy Sacred heart Hospital
Anyang, , South Korea
Dong-A university Hospital
Busan, , South Korea
Yeungnam university medical center
Daegu, , South Korea
Chungnam National University hospital
Daejeon, , South Korea
Chonnam National university medical school & Hospital
Gwangju, , South Korea
hanyang University Guri Hospital
Gyeonggi-do, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Chung-Ang University hospital
Seoul, , South Korea
Hanyang University Hospital
Special City of Seoul, , South Korea
Countries
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Other Identifiers
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238KOA12G
Identifier Type: -
Identifier Source: org_study_id
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