Efficacy and Safety of AQX-1125 in IC/BPS



Status:Completed
Conditions:Other Indications, Psychiatric, Urology, Urology
Therapuetic Areas:Nephrology / Urology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:June 2013
End Date:June 2015

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A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with
once daily administration of AQX-1125 compared to placebo on average daily pain in subjects
with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using
a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary


Inclusion Criteria:

- Be females, ≥18 and ≤75 years of age who have consistently had symptoms of bladder
pain in addition to urinary urgency and/or urinary frequency for more than 12 months

- Have had the diagnosis of interstitial cystitis for > 6 months (but pain for at least
12 months) but ≤15 years

- Have average daily pain score of at least 5 out of 10 on the 11-point NRS pain scale
in the 7 days prior to baseline

- Have undergone a cystoscopy and have documented visible signs of bladder bleeding,
lesions or glomerulation within the last 36 months prior to baseline.

- Subjects if of child bearing potential, must agree to avoid pregnancy and use
medically acceptable method of contraception from screening visit and throughout the
study.

- Must be capable of voiding independently

Exclusion Criteria:

- Pelvic floor pain (>5 out of 10 on the 11-point NRS pain scale following a pelvic
pain assessment)

- Have a body mass index [BMI] of <18 kg/m2 or >39 kg/m2

- Have had a urinary tract infection including bacterial cystitis within the past 30
days.

- Have greater than 1+ hematuria on dipstick test at screening from an unknown cause

- History of previous procedure(s) (augmentation cystoplasty, cystectomy, or
cystolysis) that has affected bladder function
We found this trial at
13
sites
Troy, Michigan
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Calgary, Alberta
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Denver, Colorado
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Desoto, Texas 75115
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Farmington, Connecticut
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Garden City, New York
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Glendora, California 91741
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Homewood, Alabama
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Homewood, AL
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Orlando, Florida
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Orlando, FL
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San Diego, California
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San Diego, CA
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Shreveport, Louisiana
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Shreveport, LA
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Toledo, Ohio
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Toledo, OH
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Winston Salem, North Carolina 27103
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Winston Salem, NC
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