Trial · NCT01882543

Efficacy and Safety of AQX-1125 in IC/BPS

NCT01882543, Phase 2, Completed, Aquinox Pharmaceuticals (Canada) Inc.; results first posted 2017-09-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of AQX-1125 in IC/BPS. Trials, record NCT01882543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01882543

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of AQX-1125 in IC/BPS
NCT number: NCT01882543
Status: Completed
Phases: Phase 2
Enrollment: 69 participants, actual
Lead sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Interventions: AQX-1125, Placebo
First posted: 2013-06-20
Last updated: 2017-09-05
Results first posted: 2017-09-05

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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'.
Secondary	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'.
Secondary	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'.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Other	AQX-1125 Concentrations in Plasma and Urine (Trough Values)	Week 4 and Week 6	AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	Baseline to 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.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	Baseline to 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.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Average Bladder Pain Score (Clinic)	Baseline to 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.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Maximum Bladder Pain Score (Clinic)	Baseline to 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.	units on a scale	MEAN
SECONDARY	Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]	Baseline to 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.	units on a scale	MEAN
SECONDARY	O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]	Baseline to 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.	units on a scale	MEAN
SECONDARY	Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire	Baseline to 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.	units on a scale	MEAN
SECONDARY	Voiding Frequency as Recorded by Diary Over a 24 Hour Period	Baseline to 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.	number of voids	MEAN
OTHER_PRE_SPECIFIED	AQX-1125 Concentrations in Plasma and Urine (Trough Values)	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.	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	AQX-1125	Baseline	6.4	Standard Error 0.14	units on a scale
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	Placebo	Baseline	6.7	Standard Error 0.18	units on a scale
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	AQX-1125	Week 6: Change from Baseline	-2.4	Standard Error 0.37	units on a scale
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)	Placebo	Week 6: Change from Baseline	-1.4	Standard Error 0.32	units on a scale
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	AQX-1125	Baseline	7.6	Standard Error 0.17	units on a scale
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	Placebo	Baseline	7.9	Standard Error 0.19	units on a scale
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	AQX-1125	Week 6: Change from Baseline	-2.6	Standard Error 0.42	units on a scale
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)	Placebo	Week 6: Change from Baseline	-1.4	Standard Error 0.35	units on a scale
Change From Baseline in the Average Bladder Pain Score (Clinic)	AQX-1125	Baseline	6.7	Standard Error 0.19	units on a scale
Change From Baseline in the Average Bladder Pain Score (Clinic)	Placebo	Baseline	6.7	Standard Error 0.20	units on a scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AQX-1125	37
Overall Study	STARTED	Placebo	32
Overall Study	COMPLETED	AQX-1125	33
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	AQX-1125	4
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal discomfort or pain (upper/lower)	Gastrointestinal disorders	AQX-1125	3	37
other	Abdominal discomfort or pain (upper/lower)	Gastrointestinal disorders	Placebo	5	32
other	Diarrhea	Gastrointestinal disorders	AQX-1125	4	37
other	Diarrhea	Gastrointestinal disorders	Placebo	4	32
other	Dyspepsia	Gastrointestinal disorders	AQX-1125	2	37
other	Dyspepsia	Gastrointestinal disorders	Placebo	0	32
other	Gastroesophageal reflux disease	Gastrointestinal disorders	AQX-1125	2	37
other	Gastroesophageal reflux disease	Gastrointestinal disorders	Placebo	1	32
other	Nausea	Gastrointestinal disorders	AQX-1125	1	37
other	Nausea	Gastrointestinal disorders	Placebo	3	32

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AQX-1125
Total, all-cause mortality	Placebo
Total, other adverse events	AQX-1125	19	37
Total, other adverse events	Placebo	25	32
Total, serious adverse events	AQX-1125	0	37
Total, serious adverse events	Placebo	0	32

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32734597	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
AQX-1125 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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