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

Primary Purpose

Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AQX-1125 200 mg
Placebo
Sponsored by
Aquinox Pharmaceuticals (Canada) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements
  • Males, ≥18 and ≤80 years of age at Screening Visit 1
  • Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)
  • Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months
  • Must be capable of voiding independently for 30 days prior to screening

Exclusion Criteria:

  • Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis
  • Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes
  • Relief of pelvic pain after voiding
  • Post-void residual volume >150 mL
  • Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1
  • History of previous prostate or bladder intervention within 1 month of Screening Visit 1, history of microwave therapy, transurethral resection of the prostate, transurethral radiofrequency thermotherapy, transurethral incision of the prostate, transurethral needle ablation, transurethral laser vaporization of the prostate, Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit 1
  • Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS
  • Ongoing, symptomatic urethral stricture disease
  • Neurologic disease or disorder affecting the bladder, ability to void spontaneously, or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic neuropathy)
  • Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam")
  • History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
  • Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment (radiation or chemotherapy) thereof
  • Major surgery within 3 months prior to Screening Visit 1
  • Have any other condition/disease which, in the opinion of the Investigator, could compromise subject safety or interfere with the subject's participation in the study or in the evaluation of the study results.

Sites / Locations

  • Site 1026
  • Site 1010
  • Site 1004
  • Site 1028
  • Site 1018
  • Site 1016
  • Site 1020
  • Site 1027
  • Site 1013
  • Site 1015
  • Site 1023
  • Site 1014
  • Site 1012
  • Site 1002
  • Site 1011
  • Site 1009
  • Site 1021
  • Site 1008
  • Site 1019
  • Site 1001
  • Site 1017
  • Site 1007
  • Site 1022
  • Site 1005
  • Site 1025
  • Site 1003
  • Site 1024

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AQX-1125

Placebo

Arm Description

AQX-1125 200 mg

Matching placebo

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
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 Outcome Measures

Change From Baseline to Week 12 in NIH-CPSI
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
Change From Baseline to Week 12 in IIEF-EF
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)
Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
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)
Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
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.
Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary)
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
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)
Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12
The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
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
The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
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
Response to Treatment
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.
Discontinuation of Study Medication Due to Treatment Failure
Frequency and Severity of Adverse Events (AEs)

Full Information

First Posted
April 4, 2018
Last Updated
December 20, 2018
Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03500159
Brief Title
Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Acronym
CP/CPPS
Official Title
A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Efficacy and Safety of AQX-1125 (200 mg) in Male Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's Decision
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aquinox Pharmaceuticals (Canada) Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, multi-center, double-blind, parallel-group study, enrolling approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week treatment with AQX-1125 (active drug) compared to placebo. The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or placebo in a 1:1 ratio across approximately 30 centers in North America (United States and Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety follow-up call at 3 months and visit at 6 months post last dose, for a total study duration of about 41 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Chronic Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AQX-1125
Arm Type
Experimental
Arm Description
AQX-1125 200 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
AQX-1125 200 mg
Other Intervention Name(s)
Rosiptor
Intervention Description
Synthetic SHIP1 activator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Appearance and weight matched tablets without the active product ingredient
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
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
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in NIH-CPSI
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
Title
Change From Baseline to Week 12 in IIEF-EF
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
Title
Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
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
Title
Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
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
Title
Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
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
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
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
Title
Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
Description
AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12
Time Frame
12 Weeks
Title
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
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
Title
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
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
Title
The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
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
Title
The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
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
Title
Response to Treatment
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
Title
Discontinuation of Study Medication Due to Treatment Failure
Time Frame
12 Weeks
Title
Frequency and Severity of Adverse Events (AEs)
Time Frame
12 Weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements Males, ≥18 and ≤80 years of age at Screening Visit 1 Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III) Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months Must be capable of voiding independently for 30 days prior to screening Exclusion Criteria: Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes Relief of pelvic pain after voiding Post-void residual volume >150 mL Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1 History of previous prostate or bladder intervention within 1 month of Screening Visit 1, history of microwave therapy, transurethral resection of the prostate, transurethral radiofrequency thermotherapy, transurethral incision of the prostate, transurethral needle ablation, transurethral laser vaporization of the prostate, Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit 1 Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS Ongoing, symptomatic urethral stricture disease Neurologic disease or disorder affecting the bladder, ability to void spontaneously, or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic neuropathy) Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam") History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment (radiation or chemotherapy) thereof Major surgery within 3 months prior to Screening Visit 1 Have any other condition/disease which, in the opinion of the Investigator, could compromise subject safety or interfere with the subject's participation in the study or in the evaluation of the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Shoskes, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 1026
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Site 1010
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site 1004
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Site 1028
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Site 1018
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Site 1016
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site 1020
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site 1027
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Site 1013
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Site 1015
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Site 1023
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Site 1014
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Site 1012
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Site 1002
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Site 1011
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Site 1009
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site 1021
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Site 1008
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 1019
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site 1001
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site 1017
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Site 1007
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Site 1022
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site 1005
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Site 1025
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Site 1003
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Site 1024
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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