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View trial details
Overview
Official protocol title:
THE LEADERSHIP 301 TRIAL: A 12-WEEK, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL-GROUP, PHASE 3 TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF 2 DOSES OF AQX-1125 TARGETING THE SHIP1 PATHWAY IN SUBJECTS WITH INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME FOLLOWED BY 14 OR 40-WEEK EXTENSION PERIODS
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.
AQX-1125
Medical condition:
The disease or condition that's being studied in the clinical trial.
INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME
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'.
AQX-1125-301
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
196524
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.
Unknown
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.
July 29, 2016
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 3
For more information:
ClinicalTrials.gov -
NCT02858453
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
Site 1013
Kelowna, British Columbia, V1W 4V5
Ontario
Site 1002
Kingston, Ontario, K7L 2V7
Site 1003
Kitchener, Ontario, N2N 2B9
Site 1005
Brampton, Ontario, L6T 4S5
Site 1006
Burlington, Ontario, L7N 3V2
Site 1010
Toronto, Ontario, M3N 3M5
Site 1015
Oakville, Ontario, I6J 3P1
Quebec
Site 1008
Sherbrooke, Quebec, J1H 5N4
Site 1016
Sherbrooke, Quebec, J1H 1Z1
