NCT01882543CompletedPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway
Aquinox Pharmaceuticals (Canada) Inc.3 sites in 1 country69 target enrollmentStarted: June 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 69
- Locations
- 3
- Primary Endpoint
- Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AQX-1125
Experimental
1 x AQX-1125 Capsule daily
Intervention: AQX-1125 (Drug)
Placebo
Placebo Comparator
1 x placebo capsule daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
Time Frame: Baseline to Week 6
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'.
Secondary Outcomes
- Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)(Baseline to Week 6)
- Change From Baseline in the Average Bladder Pain Score (Clinic)(Baseline to Week 6)
- Change From Baseline in the Maximum Bladder Pain Score (Clinic)(Baseline to Week 6)
- Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS](Baseline to Week 6)
- O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI](Baseline to Week 6)
- Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire(Baseline to Week 6)
- Voiding Frequency as Recorded by Diary Over a 24 Hour Period(Baseline to Week 6)
Investigators
Study Sites (3)
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