Clinical trial NCT01756937: Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
Official title: 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
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: 2012-12-28
Enrollment: 287
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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Lequesne's index score at 24weeks
timeFrame: baseline, 24 weeks
measure: 100mm Pain VAS
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline Lequesne's index score at 4weeks
timeFrame: baseline, 4 weeks
measure: Change from baseline Lequesne's index score at 8weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline Lequesne's index score at 16weeks
timeFrame: baseline, 16 weeks
measure: 100mm Pain VAS
timeFrame: 4weeks
measure: Global assement (Patient, Physician)
timeFrame: 4weeks
measure: administration days of the rescue medication
timeFrame: 24weeks
measure: The rate of patients who consumed the rescue medication
timeFrame: 24weeks
measure: 100mm Pain VAS
timeFrame: 8weeks
measure: 100mm Pain VAS
timeFrame: 16weeks
measure: change from baseline 100mm Pain VAS at 4weeeks
timeFrame: baseline, 4weeks
measure: change from baseline 100mm Pain VAS at 8weeeks
timeFrame: baseline, 8weeks
measure: change from baseline 100mm Pain VAS at 16weeeks
timeFrame: baseline, 16 weeks
measure: change from baseline 100mm Pain VAS at 24weeeks
timeFrame: baseline, 24 weeks
measure: Global assement (Patient, Physician)
timeFrame: 8weeks
measure: Global assement (Patient, Physician)
timeFrame: 16weeks
measure: change from baseline Global assement (Patient, Physician)
timeFrame: baseline, 16weeks
measure: Global assement (Patient, Physician)
timeFrame: 24weeks
measure: dosing quantity of the rescue medication
timeFrame: 24weeks
Other outcomes:
measure: Safety assessed by the incidence of adverse event
timeFrame: up to 24weeks
measure: laboratory test
timeFrame: up to 24weeks
measure: medication history
timeFrame: up to 24weeks
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym Universicy Sacred heart Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A university Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam university medical center
city: Daejon
country: Korea, Republic of
facility: Chungnam National University hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National university medical school & Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University hospital
city: Special City of Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University
name: Dae Hyun Yoo
role: PRINCIPAL_INVESTIGATOR
References: