Clinical trial NCT01882543: Efficacy and Safety of AQX-1125 in IC/BPS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Interstitial cystitis
Bladder pain syndrome
IC/BPS
AQX-1125
SHIP1
Lead sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)
timeFrame: Baseline to Week 6
measure: Change From Baseline in the Average Bladder Pain Score (Clinic)
timeFrame: Baseline to Week 6
measure: Change From Baseline in the Maximum Bladder Pain Score (Clinic)
timeFrame: Baseline to Week 6
measure: Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]
timeFrame: Baseline to Week 6
measure: O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]
timeFrame: Baseline to Week 6
measure: Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire
timeFrame: Baseline to Week 6
measure: Voiding Frequency as Recorded by Diary Over a 24 Hour Period
timeFrame: Baseline to Week 6
Other outcomes:
measure: AQX-1125 Concentrations in Plasma and Urine (Trough Values)
timeFrame: Week 4 and Week 6
Locations:
city: Homewood
country: United States
facility: AQX/CMX site
state: Alabama
city: Glendora
country: United States
facility: AQX/CMX site
state: California
city: San Diego
country: United States
facility: AQX/CMX site
state: California
city: Denver
country: United States
facility: AQX/CMX site
state: Colorado
city: Farmington
country: United States
facility: AQX/CMX site
state: Connecticut
city: Orlando
country: United States
facility: AQX/CMX site
state: Florida
city: Shreveport
country: United States
facility: AQX/CMX site
state: Louisiana
city: Troy
country: United States
facility: AQX/CMX site
state: Michigan
city: Garden City
country: United States
facility: AQX/CMX site
state: New York
city: Winston-Salem
country: United States
facility: AQX/CMX Site
state: North Carolina
city: Toledo
country: United States
facility: AQX/CMX site
state: Ohio
city: DeSoto
country: United States
facility: AQX/CMX site
state: Texas
city: Calgary
country: Canada
facility: AQX/CMX site
state: Alberta
city: Kelowna
country: Canada
facility: AQX/CMX site
state: British Columbia
city: Vancouver
country: Canada
facility: AQX/CMX Site
state: British Columbia
city: Victoria
country: Canada
facility: AQX/CMX site
state: British Columbia
city: Halifax
country: Canada
facility: AQX/CMX site
state: Nova Scotia
city: Barrie
country: Canada
facility: AQX/CMX site
state: Ontario
city: Brampton
country: Canada
facility: AQX/CMX site
state: Ontario
city: Brantford
country: Canada
facility: AQX/CMX site
state: Ontario
city: Burlington
country: Canada
facility: AQX/CMX site
state: Ontario
city: Kingston
country: Canada
facility: AQX/CMX site
state: Ontario
city: Kitchener
country: Canada
facility: AQX/CMX site
state: Ontario
city: Oakville
country: Canada
facility: AQX/CMX site
state: Ontario
city: Toronto
country: Canada
facility: AQX/CMX site
state: Ontario
city: Toronto
country: Canada
facility: Dr Lesley Carr
state: Ontario
city: Granby
country: Canada
facility: AQX/CMX site
state: Quebec
city: Montreal
country: Canada
facility: AQX/CMX site
state: Quebec
city: Sherbrooke
country: Canada
facility: AQX/CMX site
state: Quebec
Study officials:
affiliation: Aquinox Pharmaceuticals (Canada) Inc.
name: Stephen B Shrewsbury, MD
role: STUDY_DIRECTOR
References:
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.