Efficacy and Safety of AQX-1125 in IC/BPS

Interstitial Cystitis Clinical Trial

— LEADERSHIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882543
• Other study ID #: AQX-1125-201
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: November 20, 2015
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Aquinox Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 (but 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 NRS pain scale in the 7 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders

Intervention

Drug:
• AQX-1125
Synthetic SHIP1 activator
• Placebo
Double blind placebo capsule

Locations

Country	Name	City	State
Canada	AQX/CMX site	Barrie	Ontario
Canada	AQX/CMX site	Brampton	Ontario
Canada	AQX/CMX site	Brantford	Ontario
Canada	AQX/CMX site	Burlington	Ontario
Canada	AQX/CMX site	Calgary	Alberta
Canada	AQX/CMX site	Granby	Quebec
Canada	AQX/CMX site	Halifax	Nova Scotia
Canada	AQX/CMX site	Kelowna	British Columbia
Canada	AQX/CMX site	Kingston	Ontario
Canada	AQX/CMX site	Kitchener	Ontario
Canada	AQX/CMX site	Montreal	Quebec
Canada	AQX/CMX site	Oakville	Ontario
Canada	AQX/CMX site	Sherbrooke	Quebec
Canada	AQX/CMX site	Toronto	Ontario
Canada	Dr Lesley Carr	Toronto	Ontario
Canada	AQX/CMX Site	Vancouver	British Columbia
Canada	AQX/CMX site	Victoria	British Columbia
United States	AQX/CMX site	Denver	Colorado
United States	AQX/CMX site	Desoto	Texas
United States	AQX/CMX site	Farmington	Connecticut
United States	AQX/CMX site	Garden City	New York
United States	AQX/CMX site	Glendora	California
United States	AQX/CMX site	Homewood	Alabama
United States	AQX/CMX site	Orlando	Florida
United States	AQX/CMX site	San Diego	California
United States	AQX/CMX site	Shreveport	Louisiana
United States	AQX/CMX site	Toledo	Ohio
United States	AQX/CMX site	Troy	Michigan
United States	AQX/CMS Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aquinox Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AQX-1125 concentrations in plasma and urine (trough values)		10 weeks	No
Primary	Change from baseline in the mean daily bladder pain score	Difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale [NRS] at 2, 4 and 6 weeks recorded by e-diary	6 weeks (also at 2 and 4 weeks)	No
Secondary	Difference in the change from baseline in other symptom scores and quality of life measures	Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS], interstitial cystitis symptom index/problem index [ICSI/PI] and short form 12 version 2.0 health survey [SF-12v2] questionnaires will be completed at start and end of treatment (and BPIC-SS at 2 and 4 weeks)	2, 4 and 6 weeks	No
Secondary	Safety determined by adverse events [AEs], physical examinations, laboratory tests, electrocardiogram [ECG] and ophthalmic examinations	Adverse events will be collected from signing of informed consent until discharge from study. Other assessments will be completed at regular intervals	10 weeks	Yes

External Links

•   The Interstitial Cystitis Association (ICA) is the only nonprofit association dedicated solely to improving the quality of healthcare and lives of people living with interstitial cystitis (IC).