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

Osteoarthritis of the Knee Clinical Trial

— ABSOLUTE-OS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743287
• Other study ID #: 238KOA12F
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2012
• Last updated: April 29, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 ?~? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Imotun capsule
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: per oral, a capsule a day during 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungcheonbuk-do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chonnam National University Hwasun hospital	Hwasun
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Bundang CHA medical center	Seongnam
Korea, Republic of	ASAN Medical Center	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of adverse event		up to 24 weeks	Yes
Other	laboratory test		up to 24 weeks	Yes
Other	medication history		up to 24 weeks	Yes
Primary	100mm pain VAS	assessment of the 100mm pain VAS	24 weeks	No
Primary	change from baseline Lequesne's index score at 24 weeks		baseline, 24 weeks	No
Secondary	change from baseline Lequesne's index score at 4 weeks		baseline, 4 weeks	No
Secondary	change from baseline 100mm pain VAS at 4 weeks		baseline, 4 weeks	No
Secondary	100mm pain VAS	assessment of 100mm pain VAS	4 weeks	No
Secondary	global assessment	global assessment by physician and patient	4 weeks	No
Secondary	administration days of the rescue medication		24 weeks	No
Secondary	The rate of patients who consumed the rescue medication		24 weeks	No
Secondary	change from baseline Lequesne's index score at 8 weeks		baseline, 8 weeks	No
Secondary	change from baseline Lequesne's index score at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline 100mm pain VAS at 8 weeks		baseline, 8 weeks	No
Secondary	change from baseline 100mm pain VAS at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline 100mm pain VAS at 24 weeks		baseline, 24 weeks	No
Secondary	100mm pain VAS	assessment of 100mm pain VAS	8 weeks	No
Secondary	100mm pain VAS	assessment of 100mm pain VAS	16 weeks	No
Secondary	global assessment	global assessment by physician and patient	8 weeks	No
Secondary	global assessment	global assessment by physician and patient	16 weeks	No
Secondary	global assessment	global assessment by physician and patient	24 weeks	No
Secondary	dosing quantity of the rescue medication		24 weeks	No