Efficacy and Safety of AQX-1125 in IC/BPS

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aquinox Pharmaceuticals (Canada) Inc.

Criteria

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 (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 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