Phase 2
N=69
Efficacy and Safety of AQX-1125 in IC/BPS
Interstitial Cystitis · Bladder Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01882543 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) — 6.4; 6.7; -2.4; -1.4 units on a scale — p=0.061
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AQX-1125 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) |
6.4; 6.7; -2.4; -1.4 | 0.061 |
| SECONDARY Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) |
7.6; 7.9; -2.6; -1.4 | 0.030 sig |
| SECONDARY Change From Baseline in the Average Bladder Pain Score (Clinic) |
6.7; 6.7; -2.6; -1.1 | 0.008 sig |
| SECONDARY Change From Baseline in the Maximum Bladder Pain Score (Clinic) |
8.1; 8.0; -2.8; -1.1 | 0.028 sig |
| SECONDARY Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] |
29.6; 31.6; -8.8; -4.0 | 0.011 sig |
| SECONDARY O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] |
27.3; 30.2; -7.3; -3.0; 14.4; 16.1 | 0.007 sig |
| SECONDARY Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire |
46.4; 41.3; 0.5; 4.0; 41.4; 36.1 | 0.592 |
| SECONDARY Voiding Frequency as Recorded by Diary Over a 24 Hour Period |
15.7; 16.8; -3.6; -0.8 | 0.040 sig |
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
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01882543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.