Status:
COMPLETED
Efficacy and Safety of AQX-1125 in IC/BPS
Lead Sponsor:
Aquinox Pharmaceuticals (Canada) Inc.
Conditions:
Interstitial Cystitis
Bladder Pain Syndrome
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 (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 Numerical Rating Scale \[NRS\] pain scale in the 9 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01882543
Start Date
June 1 2013
End Date
June 1 2015
Last Update
September 5 2017
Active Locations (29)
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1
AQX/CMX site
Homewood, Alabama, United States, 35209
2
AQX/CMX site
Glendora, California, United States, 91741
3
AQX/CMX site
San Diego, California, United States, 92123
4
AQX/CMX site
Denver, Colorado, United States, 80211