Efficacy and Safety of AQX-1125 in IC/BPS

Aquinox Pharmaceuticals (Canada) Inc.69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interstitial Cystitis Bladder Pain Syndrome

Interventions

AQX-1125DRUG

Synthetic SHIP1 activator

PlaceboDRUG

Double blind placebo capsule

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (29)

AQX/CMX site

Homewood, Alabama, United States

Outcomes

Primary Outcomes

Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)

Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

Time frame: Baseline to Week 6

Secondary Outcomes

Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)

Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

Time frame: Baseline to Week 6

Change From Baseline in the Average Bladder Pain Score (Clinic)

Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

Time frame: Baseline to Week 6

Change From Baseline in the Maximum Bladder Pain Score (Clinic)

Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

Time frame: Baseline to Week 6

Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]

Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.

Data from ClinicalTrials.gov

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