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 enrollmentJune 2013

ConditionsInterstitial Cystitis Bladder Pain Syndrome

InterventionsAQX-1125 Placebo

DrugsAQX-1125 Placebo

Overview

Phase: Phase 2
Intervention: AQX-1125
Conditions: Interstitial Cystitis
Sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Enrollment: 69
Locations: 3
Primary Endpoint: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

June 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Aquinox Pharmaceuticals (Canada) Inc.

Responsible Party

Sponsor

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 \<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

1 x AQX-1125 Capsule daily

Intervention: AQX-1125

Placebo

1 x placebo capsule daily

Intervention: Placebo

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)