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Aquinox Pharmaceuticals Initiates Patient Dosing in LEADERSHIP 301 Phase 3 Clinical Trial of AQX-1125 in Interstitial Cystitis/Bladder Pain Syndrome

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Additional Relevant Details The LEADERSHIP 301 trial will enroll a minimum of 300 female patients and up to 300 male subjects at clinical research centers in Canada, the United States and Europe and will be conducted as a three arm, multicenter, randomized, doubleblind, placebo-controlled, Phase 3 clinical trial investigating the ability of 200 mg and 100 mg oral, once daily AQX-1125 to reduce bladder pain in patients with moderate to severe IC/BPS. The primary endpoint of the LEADERSHIP 301 trial will be to measure the difference in the change from baseline in the maximum daily bladder pain score based on an 11-point numeric rating scale (NRS) at twelve weeks recorded by electronic diary. The trial will also include an open-label extension of up to 40 weeks affording all participating patients the opportunity for treatment with AQX-1125. Secondary endpoints will include urinary symptoms, including frequency and nighttime awakenings, as well as measures of quality of life. Top-line data from the LEADERSHIP 301 trial is anticipated in the fourth quarter of 2017. For more information on the LEADERSHIP 301 trial, please visit www.clinicaltrials.gov.


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Catalyst Date
Occurred on:
Sep 06, 2016
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Related Keywords Leadership 301, Aqx-1125, Interstitial Cystitis, Bladder Pain Syndrome