Efficacy and Safety of AQX-1125 in IC/BPS

Phase 2

Completed

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis
• Interventions: Drug: Placebo; Drug: AQX-1125

• Registration Number: NCT01882543
• Lead Sponsor: Aquinox Pharmaceuticals (Canada) Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-20
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-05-05
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Results First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 x placebo capsule daily
AQX-1125	AQX-1125	1 x AQX-1125 Capsule daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	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 Outcome Measures

Name	Time	Method
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	Baseline to Week 6	Change from baseline to week 6 in the maximum 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'.
Change From Baseline in the Average Bladder Pain Score (Clinic)	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 at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.
Change From Baseline in the Maximum Bladder Pain Score (Clinic)	Baseline to Week 6	Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.
Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]	Baseline to Week 6	Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]	Baseline to Week 6	Change from baseline to week 6 in the O'Leary Sant Symptom and Problem Index combined total scores. Both the ICSI and ICPI consist of 4 questions with responses for the ICSI rated on a scale of 0-5 (maximum score of 20, with a higher score indicating worse symptoms) and for the ICPI on a scale of 0-4 (maximum score of 16, with a higher score indicating worse symptoms). For the combined ICSI/PI the maximum score is 36, with a higher score indicating worse symptoms.
Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire	Baseline to Week 6	Change from baseline to week 6 in the SF-12v2 questionnaire. Two parameters, PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better Quality of Life.
Voiding Frequency as Recorded by Diary Over a 24 Hour Period	Baseline to Week 6	For a 24-hour period (within 3 days of the subsequent visit), subjects recorded the frequency of each void prior to visit. The outcome measure was the change from baseline at week 6.

Trial Locations

Locations (3)

AQX/CMX Site; 🇨🇦 Vancouver, British Columbia, Canada

Dr Lesley Carr; 🇨🇦 Toronto, Ontario, Canada

AQX/CMX site; 🇨🇦 Sherbrooke, Quebec, Canada