Efficacy and Safety of AQX-1125 in IC/BPS

Completed · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis, Bladder Pain Syndrome

In brief

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

Key facts

Study ID

NCT01882543

Run by

Aquinox Pharmaceuticals (Canada) Inc.

People needed

69

Starts

2013-06-01

Expected to finish

2015-06-01

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AQX/CMX site — Homewood, Alabama, United States
• AQX/CMX site — Glendora, California, United States
• AQX/CMX site — San Diego, California, United States
• AQX/CMX site — Denver, Colorado, United States
• AQX/CMX site — Farmington, Connecticut, United States
• AQX/CMX site — Orlando, Florida, United States
• AQX/CMX site — Shreveport, Louisiana, United States
• AQX/CMX site — Troy, Michigan, United States
• AQX/CMX site — Garden City, New York, United States
• AQX/CMX Site — Winston-Salem, North Carolina, United States
• AQX/CMX site — Toledo, Ohio, United States
• AQX/CMX site — DeSoto, Texas, United States
• AQX/CMX site — Calgary, Alberta, Canada
• AQX/CMX site — Kelowna, British Columbia, Canada
• AQX/CMX Site — Vancouver, British Columbia, Canada
• AQX/CMX site — Victoria, British Columbia, Canada
• AQX/CMX site — Halifax, Nova Scotia, Canada
• AQX/CMX site — Barrie, Ontario, Canada
• AQX/CMX site — Brampton, Ontario, Canada
• AQX/CMX site — Brantford, Ontario, Canada
• AQX/CMX site — Burlington, Ontario, Canada
• AQX/CMX site — Kingston, Ontario, Canada
• AQX/CMX site — Kitchener, Ontario, Canada
• AQX/CMX site — Oakville, Ontario, Canada
• AQX/CMX site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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