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

Use our guide to learn which trials are right for you!

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
Denver, Colorado
818
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Calgary, Alberta
1189
mi
from 91732
Calgary,
Click here to add this to my saved trials
Desoto, Texas 75115
1223
mi
from 91732
Desoto, TX
Click here to add this to my saved trials
Farmington, Connecticut
2489
mi
from 91732
Farmington, CT
Click here to add this to my saved trials
Garden City, New York
2452
mi
from 91732
Garden City, NY
Click here to add this to my saved trials
Glendora, California 91741
9
mi
from 91732
Glendora, CA
Click here to add this to my saved trials
Homewood, Alabama
1786
mi
from 91732
Homewood, AL
Click here to add this to my saved trials
Orlando, Florida
2184
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
San Diego, California
106
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
Shreveport, Louisiana
1401
mi
from 91732
Shreveport, LA
Click here to add this to my saved trials
Toledo, Ohio
1936
mi
from 91732
Toledo, OH
Click here to add this to my saved trials
Troy, Michigan
1963
mi
from 91732
Troy, MI
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
2122
mi
from 91732
Winston Salem, NC
Click here to add this to my saved trials