Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis of the knee
Brief summary
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
Interventions
DRUGImotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
DRUGPlacebo
1 capsule once daily for 24 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100mm Pain VAS | 24 weeks | assessment of 100mm Pain VAS (24weekS) |
| Change from baseline in the Lequesne's index score at 24weeks | baseline, 24 weeks | Change from baseline in the Lequesne's index score at 24weekS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Lequesne's index score at 8weeks | baseline, 8 weeks | Change from baseline Lequesne's index score at 8weeks |
| Change from baseline Lequesne's index score at 16weeks | baseline, 16 weeks | Change from baseline Lequesne's index score at 16weeks |
| 100mm Pain VAS | 4weeks | \- Patient's assessment of 100mm Pain VAS |
| Global assement (Patient, Physician) | 4weeks | -Global assement (Patient, Physician) |
| administration days of the rescue medication | 24weeks | administration days of the rescue medication |
| The rate of patients who consumed the rescue medication | 24weeks | The rate of patients who consumed the rescue medication |
| Change from baseline Lequesne's index score at 4weeks | baseline, 4 weeks | Change from baseline Lequesne's index score at 4weeks |
| change from baseline 100mm Pain VAS at 24weeeks | baseline, 24 weeks | change from baseline 100mm Pain VAS at 24weeeks |
| change from baseline Global assement (Patient, Physician) | baseline, 16weeks | -Global assement (Patient, Physician) |
| dosing quantity of the rescue medication | 24weeks | dosing quantity of the rescue medication |
| change from baseline 100mm Pain VAS at 4weeeks | baseline, 4weeks | change from baseline 100mm Pain VAS at 4weeeks |
| change from baseline 100mm Pain VAS at 8weeeks | baseline, 8weeks | change from baseline 100mm Pain VAS at 8weeeks |
| change from baseline 100mm Pain VAS at 16weeeks | baseline, 16 weeks | change from baseline 100mm Pain VAS at 16weeeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the incidence of adverse event | up to 24weeks | Safety assessed by the incidence of adverse event |
| medication history | up to 24weeks | medication history |
| laboratory test | up to 24weeks | laboratory test |
Countries
South Korea
Outcome results
None listed