Clinical trial NCT01743287: The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis of the knee
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 234
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 (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

Primary outcomes:
measure: 100mm pain VAS
timeFrame: 24 weeks
measure: change from baseline Lequesne's index score at 24 weeks
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: change from baseline Lequesne's index score at 4 weeks
timeFrame: baseline, 4 weeks
measure: change from baseline 100mm pain VAS at 4 weeks
timeFrame: baseline, 4 weeks
measure: 100mm pain VAS
timeFrame: 4 weeks
measure: global assessment
timeFrame: 4 weeks
measure: administration days of the rescue medication
timeFrame: 24 weeks
measure: The rate of patients who consumed the rescue medication
timeFrame: 24 weeks
measure: change from baseline Lequesne's index score at 8 weeks
timeFrame: baseline, 8 weeks
measure: change from baseline Lequesne's index score at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline 100mm pain VAS at 8 weeks
timeFrame: baseline, 8 weeks
measure: change from baseline 100mm pain VAS at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline 100mm pain VAS at 24 weeks
timeFrame: baseline, 24 weeks
measure: 100mm pain VAS
timeFrame: 8 weeks
measure: 100mm pain VAS
timeFrame: 16 weeks
measure: global assessment
timeFrame: 8 weeks
measure: global assessment
timeFrame: 16 weeks
measure: global assessment
timeFrame: 24 weeks
measure: dosing quantity of the rescue medication
timeFrame: 24 weeks
Other outcomes:
measure: rate of adverse event
timeFrame: up to 24 weeks
measure: laboratory test
timeFrame: up to 24 weeks
measure: medication history
timeFrame: up to 24 weeks
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheonbuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Myung Chul Lee, phD
role: PRINCIPAL_INVESTIGATOR
References: