NCT01756937

Brief Summary

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

October 30, 2012

Last Update Submit

March 24, 2017

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee

Outcome Measures

Primary Outcomes (2)

  • 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

  • 100mm Pain VAS

    assessment of 100mm Pain VAS (24weekS)

    24 weeks

Secondary Outcomes (18)

  • Change from baseline Lequesne's index score at 4weeks

    baseline, 4 weeks

  • Change from baseline Lequesne's index score at 8weeks

    baseline, 8 weeks

  • Change from baseline Lequesne's index score at 16weeks

    baseline, 16 weeks

  • 100mm Pain VAS

    4weeks

  • Global assement (Patient, Physician)

    4weeks

  • +13 more secondary outcomes

Other Outcomes (3)

  • Safety assessed by the incidence of adverse event

    up to 24weeks

  • laboratory test

    up to 24weeks

  • medication history

    up to 24weeks

Study Arms (2)

Imotun

ACTIVE COMPARATOR

300.03mg/cap,orally, 1 capsule once daily for 24 weeks

Drug: Imotun

Placebo

PLACEBO COMPARATOR

1 capsule once daily for 24 weeks

Drug: Placebo

Interventions

ImotunDRUG

300.03mg/cap,orally, 1 capsule once daily for 24 weeks

Also known as: Avocado-Soya Unsaponifiables 300.03mg/Cap
Imotun
PlaceboDRUG

1 capsule once daily for 24 weeks

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hallym Universicy Sacred heart Hospital

Anyang, 431-070, South Korea

Location

Dong-A university Hospital

Busan, 602-715, South Korea

Location

Yeungnam university medical center

Daegu, 705-035, South Korea

Location

Chungnam National University hospital

Daejeon, 301-721, South Korea

Location

Chonnam National university medical school & Hospital

Gwangju, 501-757, South Korea

Location

hanyang University Guri Hospital

Gyeonggi-do, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Chung-Ang University hospital

Seoul, 156-755, South Korea

Location

Hanyang University Hospital

Special City of Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Capsules

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Dae Hyun Yoo

    Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

December 28, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

KR(9)