Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-R)

Chong Kun Dang

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Placebo

Drug: Imotun

Study type

Interventional

Funder types

Industry

Identifiers

NCT01756937

238KOA12G

Details and patient eligibility

About

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

Full 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

Enrollment

287 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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