Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

— ABSOLUTE-R  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756937
• Other study ID #: 238KOA12G
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2012
• Last updated: March 24, 2017
• Start date: January 2013
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Imotun
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
• Placebo
1 capsule once daily for 24 weeks

Locations

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