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Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome

NCT02858453 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2018-03-15

No results posted yet for this study

Summary

This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.

Conditions

  • Interstitial Cystitis
  • Bladder Pain Syndrome
  • Painful Bladder Syndrome
  • Chronic Interstitial Cystitis

Interventions

DRUG

AQX-1125 100 mg

Synthetic SHIP1 activator

DRUG

AQX-1125 200 mg

Synthetic SHIP1 activator

DRUG

Placebo

Appearance and weight matched placebo tablets

Sponsors & Collaborators

  • Aquinox Pharmaceuticals (Canada) Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Moldwin, MD · Hofstra Northwell School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-08-31
Completion
2020-02-29

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02858453 on ClinicalTrials.gov