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View trial details
Overview
Official protocol title:
A DOUBLE-BLIND, PLACEBO-CONTROLLED, 4-ARM, PHASE 2B STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 14-DAY DOSING REGIMEN OF 3 DOSES OF ATB-346 VERSUS PLACEBO, ORALLY ADMINISTERED ONCE DAILY TO MALE AND FEMALE PATIENTS DIAGNOSED WITH OSTEOARTHRITIS OF THE KNEE
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
ATB-346
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
ATB-346-P2B-DRF
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
223366
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Closed
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
January 17, 2019
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 2
For more information:
ClinicalTrials.gov -
NCT03978208
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
No
Locations
British Columbia
Dr. MB Jones Inc
Victoria, British Columbia, V8V 4A1
James K. Lai MD Inc
Vancouver, British Columbia, V5Z 1K3
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Viable Clinical Research Corp
Mission, British Columbia, V2V 1C6
Nova Scotia
True North Clinical Research Inc.
Halifax, Nova Scotia, B3S 1M7
Ontario
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Bluewater Clinical Research Group Inc
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Clinical Research& Arthritis Centre
Windsor, Ontario, N8X 2C9
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5
Dr. Allen Greenspoon Medicine Professional Corporation
Hamilton, Ontario, L8L 5G8
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Dr. Steven V. Zizzo Medicine Professional Corporation
Stoney Creek, Ontario, L8J 0B6
Etobicoke Medical Centre
Etobicoke, Ontario, M8Z 5W4
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
King Street Medical Clinic
LMC Clinical Research Inc
Toronto, Ontario, M4G 3E8
Malton Medical Clinic
Mississauga, Ontario, L4V 1P1
Manna Research (Burlington North)
Burlington, Ontario, L7M 4Y1
Manna Research (Stoney Creek)
Stoney Creek, Ontario, L8J 3W2
Manna Research (Toronto)
Toronto, Ontario, M9W 4L6
SKDS Research Inc
Newmarket, Ontario, L3Y 5G8
Viable Clinical Research Corp
Scarborough Village, Ontario, M1P 2T7
Quebec
Centre de Recherche Saint-Louis
Centre Medical Acadie
Montreal, Quebec, H4N 2W2
Diex Recherche Quebec Inc.
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6
Manna Research (Mirabel QC)
Manna Research (Montreal)
Pointe-Claire, Quebec, H9R 4S3
Recherche GCP Research
Montreal, Quebec, H1M 1B1