Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis of the knee
Brief summary
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.
Interventions
DRUGImotun capsule
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
DRUGImotun capsule placebo
Imotun capsule placebo: per oral, a capsule a day during 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
* 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
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(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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline Lequesne's index score at 24 weeks | baseline, 24 weeks | — |
| 100mm pain VAS | 24 weeks | assessment of the 100mm pain VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline 100mm pain VAS at 24 weeks | baseline, 24 weeks | — |
| dosing quantity of the rescue medication | 24 weeks | — |
| change from baseline Lequesne's index score at 4 weeks | baseline, 4 weeks | — |
| change from baseline 100mm pain VAS at 4 weeks | baseline, 4 weeks | — |
| 100mm pain VAS | 4 weeks | assessment of 100mm pain VAS |
| global assessment | 4 weeks | global assessment by physician and patient |
| administration days of the rescue medication | 24 weeks | — |
| The rate of patients who consumed the rescue medication | 24 weeks | — |
| change from baseline Lequesne's index score at 8 weeks | baseline, 8 weeks | — |
| change from baseline Lequesne's index score at 16 weeks | baseline, 16 weeks | — |
| change from baseline 100mm pain VAS at 8 weeks | baseline, 8 weeks | — |
| change from baseline 100mm pain VAS at 16 weeks | baseline, 16 weeks | — |
Other
| Measure | Time frame |
|---|---|
| rate of adverse event | up to 24 weeks |
| medication history | up to 24 weeks |
| laboratory test | up to 24 weeks |
Countries
South Korea
Outcome results
None listed