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Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03500159
Recruitment Status : Terminated (Sponsor's Decision)
First Posted : April 17, 2018
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Aquinox Pharmaceuticals (Canada) Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Interventions Drug: AQX-1125 200 mg
Drug: Placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AQX-1125 Placebo
Hide Arm/Group Description

AQX-1125 200 mg

AQX-1125 200 mg: Synthetic SHIP1 activator

Matching placebo

Placebo: Appearance and weight matched tablets without the active product ingredient

Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Reason Not Completed
Study Terminated             2             1
Arm/Group Title AQX-1125 Placebo Total
Hide Arm/Group Description

AQX-1125 200 mg

AQX-1125 200 mg: Synthetic SHIP1 activator

Matching placebo

Placebo: Appearance and weight matched tablets without the active product ingredient

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
55.5  (6.36) 50.0  (0.00) 53.66  (5.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
1
 100.0%
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
1
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  50.0%
0
   0.0%
1
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  50.0%
0
   0.0%
1
  33.3%
White
0
   0.0%
1
 100.0%
1
  33.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
Hide Description 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)
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prematurely, no analysis was performed
Arm/Group Title AQX-1125 Placebo
Hide Arm/Group Description:

AQX-1125 200 mg

AQX-1125 200 mg: Synthetic SHIP1 activator

Matching placebo

Placebo: Appearance and weight matched tablets without the active product ingredient

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline to Week 12 in NIH-CPSI
Hide Description 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
Time Frame 12 Weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change From Baseline to Week 12 in IIEF-EF
Hide Description 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)
Time Frame 12 Weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
Hide Description 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)
Time Frame 12 Weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
Hide Description 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.
Time Frame 12 Weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
Hide Description Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary)
Time Frame 12 Weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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
Hide Description 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)
Time Frame 16 Weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
Hide Description AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12
Time Frame 12 Weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
Hide Description AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12
Time Frame 12 Weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
Hide Description AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12
Time Frame 12 Weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
Hide Description Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement in maximum daily pelvic pain (mean) based on a standardized 11-point numeric rating scale (NRS) recorded by eDiary at Week 6 and 12
Time Frame 12 Weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
Hide Description Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement NIH-CPSI subscale at Week 6 and 12
Time Frame 12 Weeks
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Response to Treatment
Hide Description Response to treatment as defined by a decrease in maximum daily pelvic pain (eDiary) at Week 12 with a decrease or no change to concomitant analgesic medication use.
Time Frame 12 Weeks
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Discontinuation of Study Medication Due to Treatment Failure
Hide Description [Not Specified]
Time Frame 12 Weeks
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Frequency and Severity of Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame 12 Weeks
Outcome Measure Data Not Reported
Time Frame 16 Weeks (12 weeks treatment period and 4 week post last dose follow up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AQX-1125 Placebo
Hide Arm/Group Description

AQX-1125 200 mg

AQX-1125 200 mg: Synthetic SHIP1 activator

Matching placebo

Placebo: Appearance and weight matched tablets without the active product ingredient

All-Cause Mortality
AQX-1125 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AQX-1125 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AQX-1125 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Restrictions are specific to applicable clinical trial agreements with PI(s)
Results Point of Contact
Name/Title: Clinical
Organization: Aquinox Pharmaceuticals (Canada) Inc.
Phone: 604-629-9223
Responsible Party: Aquinox Pharmaceuticals (Canada) Inc.
ClinicalTrials.gov Identifier: NCT03500159     History of Changes
Other Study ID Numbers: AQX-1125-205
First Submitted: April 4, 2018
First Posted: April 17, 2018
Results First Submitted: December 20, 2018
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019