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Trial Outcomes & Findings for Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NCT NCT03500159)

NCT ID: NCT03500159

Last Updated: 2019-01-09

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

12 Weeks

Results posted on

2019-01-09

Participant Flow

Participant milestones

Participant milestones
Measure
AQX-1125
AQX-1125 200 mg AQX-1125 200 mg: Synthetic SHIP1 activator
Placebo
Matching placebo Placebo: Appearance and weight matched tablets without the active product ingredient
Overall Study
STARTED
2
1
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
AQX-1125
AQX-1125 200 mg AQX-1125 200 mg: Synthetic SHIP1 activator
Placebo
Matching placebo Placebo: Appearance and weight matched tablets without the active product ingredient
Overall Study
Study Terminated
2
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AQX-1125
n=2 Participants
AQX-1125 200 mg AQX-1125 200 mg: Synthetic SHIP1 activator
Placebo
n=1 Participants
Matching placebo Placebo: Appearance and weight matched tablets without the active product ingredient
Total
n=3 Participants
Total of all reporting groups
Age, Continuous
55.5 years
STANDARD_DEVIATION 6.36 • n=99 Participants
50.0 years
STANDARD_DEVIATION 0.00 • n=107 Participants
53.66 years
STANDARD_DEVIATION 5.51 • n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
2 participants
n=99 Participants
1 participants
n=107 Participants
3 participants
n=206 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: Study was terminated prematurely, no analysis was performed

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome data not reported

Adverse Events

AQX-1125

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical

Aquinox Pharmaceuticals (Canada) Inc.

Phone: 604-629-9223

Results disclosure agreements

  • Principal investigator is a sponsor employee Restrictions are specific to applicable clinical trial agreements with PI(s)
  • Publication restrictions are in place

Restriction type: OTHER