This study is evaluating the safety and effectiveness of an investigational drug, AQX-1125, for reducing pain and relieving other symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The study includes a treatment phase to evaluate two doses of oral AQX-1125 compared to a placebo control group. Patients will be in the study for up to one year and will be asked to complete daily e-diaries to record pain scores and urination frequency.
- Trial ID:
- Bruce Kahn, M.D.
- be over 18 years of age
- have a diagnosis of IC/BPS or consistent symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months.
- meet all other eligibility criteria
- have had the clinical diagnosis of Iterstitial Cystitis.
- have Pelvic floor pain <7 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment.
- Be post-menopausal for a minimum of 1 year
- have a pain score of more than 30 as determined by the Pain Scale
- have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days
- have a history of chronic substance abuse or dependency within the last 2 years
- have taken oral steroids within the past 30 days
- have taken antihistamines or NSAIDs for more than 30 days (unless on a stable dose)
- have a history of bladder tumors or uterine, cervical, vaginal or urethral cancer
- Patients will be randomized to receive either 100 mg or 200mg of AQX-1125, or placebo for the first 12 weeks of the study. After 12 weeks all patients will enter the extension period and patients in the placebo group will also be randomized to receive either 100 mg or 200 mg AQX-1125 for 14 or 40 weeks.