The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-OS)

Chong Kun Dang

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Imotun capsule placebo

Drug: Imotun capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01743287

238KOA12F

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Full 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.

Enrollment

234 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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