Efficacy and Safety of AQX-1125 in IC/BPS (LEADERSHIP)

Aquinox Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Treatments

Drug: Placebo

Drug: AQX-1125

Study type

Interventional

Funder types

Industry

Identifiers

NCT01882543

AQX-1125-201

Details and patient eligibility

About

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

Enrollment

69 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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