Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05752032




Registration number
NCT05752032
Ethics application status
Date submitted
21/02/2023
Date registered
2/03/2023

Titles & IDs
Public title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Scientific title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Secondary ID [1] 0 0
ICM 20-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - ICM-203
Treatment: Drugs - Placebo

ICM-203 - Participants who previously received ICM-203 in ICM-203 clinical studies

Placebo - Participants who previously received placebo in ICM-203 clinical studies


Treatment: Other: ICM-203
Long term follow-up

Treatment: Drugs: Placebo
Long term follow-up
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of delayed adverse events
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Knee pain
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Knee function
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Joint space width
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Incidence of total knee replacement
Timepoint [5] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
* Previous receipt of ICM-203 or matching placebo
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ICM Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alison Heald, MD
Address 0 0
ICM Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05752032