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

Chronic Pelvic Pain Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03500159
• Other study ID #: AQX-1125-205
• Status: Terminated
• Phase: Phase 2
• Start date: April 18, 2018
• Est. completion date: July 17, 2018

Study information

• Verified date: December 2018
• Source: Aquinox Pharmaceuticals (Canada) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• AQX-1125 200 mg
Synthetic SHIP1 activator
• Placebo
Appearance and weight matched tablets without the active product ingredient

Locations

Country	Name	City	State
Canada	Site 1005	Brampton	Ontario
Canada	Site 1025	Kingston	Ontario
Canada	Site 1003	Oakville	Ontario
Canada	Site 1024	Toronto	Ontario
United States	Site 1011	Albuquerque	New Mexico
United States	Site 1021	Charlotte	North Carolina
United States	Site 1001	Cleveland	Ohio
United States	Site 1013	Coeur d'Alene	Idaho
United States	Site 1022	Dallas	Texas
United States	Site 1026	Homewood	Alabama
United States	Site 1023	Jeffersonville	Indiana
United States	Site 1028	Laguna Hills	California
United States	Site 1009	Lake Success	New York
United States	Site 1018	Los Alamitos	California
United States	Site 1016	Los Angeles	California
United States	Site 1020	Los Angeles	California
United States	Site 1010	Mobile	Alabama
United States	Site 1027	New Port Richey	Florida
United States	Site 1017	Oklahoma City	Oklahoma
United States	Site 1007	Philadelphia	Pennsylvania
United States	Site 1008	Raleigh	North Carolina
United States	Site 1002	Royal Oak	Michigan
United States	Site 1012	Shreveport	Louisiana
United States	Site 1015	Springfield	Illinois
United States	Site 1004	Tucson	Arizona
United States	Site 1014	West Des Moines	Iowa
United States	Site 1019	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aquinox Pharmaceuticals (Canada) Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 Weeks
Secondary	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	12 Weeks
Secondary	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)	12 Weeks
Secondary	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)	12 Weeks
Secondary	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.	12 Weeks
Secondary	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)	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	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)	16 Weeks
Secondary	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	12 Weeks
Secondary	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	12 Weeks
Secondary	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	12 Weeks
Secondary	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	12 Weeks
Secondary	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	12 Weeks
Secondary	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.	12 Weeks
Secondary	Discontinuation of Study Medication Due to Treatment Failure		12 Weeks
Secondary	Frequency and Severity of Adverse Events (AEs)		12 Weeks