The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

NCT ID: NCT01743287

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Imotun capsule

Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks

Group Type: EXPERIMENTAL

Imotun capsule

Intervention Type: DRUG

Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks

Imotun capsule placebo

Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks

Group Type: PLACEBO_COMPARATOR

Imotun capsule placebo

Intervention Type: DRUG

Imotun capsule placebo: per oral, a capsule a day during 24 weeks

Interventions

Imotun capsule

Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks

Intervention Type: DRUG

Imotun capsule placebo

Imotun capsule placebo: per oral, a capsule a day during 24 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung Chul Lee, phD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Chungbuk National University Hospital

Cheongju-si, Chungcheonbuk-do, South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Chonnam National University Hwasun hospital

Hwasun, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Bundang CHA medical center

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

KyungHee University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

ASAN Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

238KOA12F

Identifier Type: -

Identifier Source: org_study_id