Trial · NCT03500159
Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
NCT03500159, Phase 2, Terminated, Aquinox Pharmaceuticals (Canada) Inc.; results first posted 2019-01-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Trials, record NCT03500159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03500159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- NCT number
- NCT03500159
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Interventions
- AQX-1125 200 mg, Placebo
- First posted
- 2018-04-17
- Last updated
- 2019-01-09
- Results first posted
- 2019-01-09
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean) | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary) |
| Secondary | Change From Baseline to Week 12 in NIH-CPSI | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscale and all domains total score |
| Secondary | Change From Baseline to Week 12 in IIEF-EF | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in Male sexual health as measured using the International Index of Erectile Function Questionnaire, Erectile Function Domain (IIEF-EF) |
| Secondary | Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary), | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary) |
| Secondary | Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average and maximum pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded on paper-based questionnaire at clinic visits. |
| Secondary | Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary) | 12 Weeks | Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary) |
| Secondary | Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints | 16 Weeks | Change from Baseline at each clinic visit for AQX-1125 200 mg compared to placebo for; Mean of maximum daily pelvic pain score (eDiary), NIH-CPSI pain subscale and all domains total score, IIEF-EF, Mean of average daily pelvic pain scores (eDiary), average and maximum pelvic pain (Paper-based NRS in clinic), and 24-hour voiding frequency (eDiary) |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12 |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12 |
| Secondary | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S | 12 Weeks | AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean) | 12 Weeks | Study was terminated prematurely, no analysis was performed | ||
| SECONDARY | Change From Baseline to Week 12 in NIH-CPSI | 12 Weeks | |||
| SECONDARY | Change From Baseline to Week 12 in IIEF-EF | 12 Weeks | |||
| SECONDARY | Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary), | 12 Weeks | |||
| SECONDARY | Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic | 12 Weeks | |||
| SECONDARY | Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary) | 12 Weeks | |||
| SECONDARY | Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints | 16 Weeks | |||
| SECONDARY | Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA | 12 Weeks | |||
| SECONDARY | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C | 12 Weeks | |||
| SECONDARY | Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S | 12 Weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AQX-1125 | 2 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | AQX-1125 | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | AQX-1125 | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AQX-1125 | 0 | 2 |
| Total, all-cause mortality | Placebo | 0 | 1 |
| Total, other adverse events | AQX-1125 | 0 | 2 |
| Total, other adverse events | Placebo | 0 | 1 |
| Total, serious adverse events | AQX-1125 | 0 | 2 |
| Total, serious adverse events | Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AQX-1125 vs Placebo: deaths from any cause | Trial comparisons |
| AQX-1125 vs Placebo: serious adverse events | 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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03500159
GET https://conductscience.org/api/trials/v1/NCT03500159/registered