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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQX-1125 | Experimental | 1 x AQX-1125 Capsule daily |
|
| Placebo | Placebo Comparator | 1 x placebo capsule daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQX-1125 | Drug | Synthetic SHIP1 activator |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) | 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'. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) | 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'. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| AQX-1125 Concentrations in Plasma and Urine (Trough Values) | AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6. | Week 4 and Week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen B Shrewsbury, MD | Aquinox Pharmaceuticals (Canada) Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AQX/CMX site | Homewood | Alabama | 35209 | United States | ||
| AQX/CMX site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734597 | Derived | 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. |
| Label | URL |
|---|---|
| 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). | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AQX-1125 | 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator |
| FG001 | Placebo | 1 x placebo capsule daily Placebo: Double blind placebo capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Double blind placebo capsule |
|
| Change From Baseline in the Average Bladder Pain Score (Clinic) |
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'. |
| Baseline to Week 6 |
| Change From Baseline in the Maximum Bladder Pain Score (Clinic) | 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'. | Baseline to Week 6 |
| Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] | 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. | Baseline to Week 6 |
| O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] | 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. | Baseline to Week 6 |
| Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire | 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. | Baseline to Week 6 |
| Voiding Frequency as Recorded by Diary Over a 24 Hour Period | 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. | Baseline to Week 6 |
| Glendora |
| California |
| 91741 |
| United States |
| AQX/CMX site | San Diego | California | 92123 | United States |
| AQX/CMX site | Denver | Colorado | 80211 | United States |
| AQX/CMX site | Farmington | Connecticut | 06032 | United States |
| AQX/CMX site | Orlando | Florida | 32801 | United States |
| AQX/CMX site | Shreveport | Louisiana | 71106 | United States |
| AQX/CMX site | Troy | Michigan | 48084 | United States |
| AQX/CMX site | Garden City | New York | 11530 | United States |
| AQX/CMX Site | Winston-Salem | North Carolina | 27103 | United States |
| AQX/CMX site | Toledo | Ohio | 43615 | United States |
| AQX/CMX site | DeSoto | Texas | 75115 | United States |
| AQX/CMX site | Calgary | Alberta | T2V1P9 | Canada |
| AQX/CMX site | Kelowna | British Columbia | Canada |
| AQX/CMX Site | Vancouver | British Columbia | V6Z1Y6 | Canada |
| AQX/CMX site | Victoria | British Columbia | Canada |
| AQX/CMX site | Halifax | Nova Scotia | B3H2Y9 | 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 | Kingston | Ontario | Canada |
| AQX/CMX site | Kitchener | Ontario | Canada |
| AQX/CMX site | Oakville | Ontario | Canada |
| AQX/CMX site | Toronto | Ontario | Canada |
| Dr Lesley Carr | Toronto | Ontario | Canada |
| AQX/CMX site | Granby | Quebec | Canada |
| AQX/CMX site | Montreal | Quebec | Canada |
| AQX/CMX site | Sherbrooke | Quebec | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AQX-1125 | 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator |
| BG001 | Placebo | 1 x placebo capsule daily Placebo: Double blind placebo capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Duration of Diagnosis | Mean | Standard Deviation | Months |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) | 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'. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) | 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'. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Change From Baseline in the Average Bladder Pain Score (Clinic) | 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'. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Change From Baseline in the Maximum Bladder Pain Score (Clinic) | 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'. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] | 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. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] | 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. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire | 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. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Voiding Frequency as Recorded by Diary Over a 24 Hour Period | 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. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Error | number of voids | Baseline to Week 6 |
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| Other Pre-specified | AQX-1125 Concentrations in Plasma and Urine (Trough Values) | AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6. | The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Week 4 and Week 6 |
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Adverse events were collected from signing of informed consent until discharge from study at Week 10
Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AQX-1125 | 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator | 0 | 37 | 19 | 37 | ||
| EG001 | Placebo | 1 x placebo capsule daily Placebo: Double blind placebo capsule | 0 | 32 | 25 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort or pain (upper/lower) | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Edema (including peripheral) | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis + vital sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Increased blood pressure | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Interstitial Cystitis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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1st publication to be a joint publication within 18 months of completion or termination of the trial at all sites. If not done the PI can publish separately, pending sponsor review 60 days prior to publication. PI agrees to remove sponsor confidential info. If sponsor identifies info it wishes to obtain IP protection for, PI agrees to remove sponsor identified info, or delay publication until the sponsor obtains IP protection and 120 calendar days from 1st submission for review to sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Curtis Nickel | Department of Urology, Queens University, Ontario | 613-548-2497 | jcn@queensu.ca |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C582990 | 4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol |
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| >=65 years |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Plasma Week 4 |
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| Plasma Week 6 |
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| Urine Week 4 |
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| Urine Week 6 |
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