bladder pain syndrome Interstitial cystitis
Conditions
Interventions
Sponsors
Aquinox Pharmaceuticals (Canada) Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For inclusion in to the screening period subjects must meet the following criteria:;1. Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements.;2. Males/females, *18 and *80 years of age at Screening Visit 1.;3. Subjects who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months (to ensure a properly established diagnosis).;4. Have had the clinical diagnosis, or history consistent with the diagnosis, of IC/BPS for >3 months but *20 years (to ensure a properly established diagnosis).;5. BPIC-SS minimum score as per the study protocol.;6. ICSI minimum score as per the study protocol.;7. Pelvic floor pain maximum score as per the study protocol on the 11-point NRS pain scale following a pelvic pain assessment (to discriminate between bladder pain and perineal/pelvic floor pain masquerading as bladder pain).;8. Must be capable of voiding independently (to allow completion of voiding diary over a 24 hour period).;9. Subjects must fulfil at least one of the following criteria:;* Males/females surgically sterile for a minimum of 6 months; or;o Females: Post-menopausal for a minimum of 1 year; or ;o If of child bearing potential, must have a negative pregnancy test and agree to avoid pregnancy and use a highly effective method of contraception with one additional barrier method of contraception from Screening Visit 1 to the final Follow-up Visit of the study (or until at least 28 days after the last dose of study drug has been taken). ;o Acceptable methods of highly effective contraception include non-hormonal intrauterine device, intrauterine hormone-releasing system or hormonal contraception (patch, injectable or implantable). Acceptable barrier methods include male condom, diaphragm, cap or sponge, or vasectomy of sole sexual partner.;o If using oral hormonal contraception, the barrier method used must include spermicide.;o True abstinence can be used as a method of contraception, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.;o Males: Must use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after last dose of study drug has been taken, unless they have been surgically sterilized (vasectomy).;10. Women of child bearing potential must have a negative pregnancy test at Screening Visit 1, Baseline (Visit 2) and throughout the study.;11. Females are non-lactating (Screening Visit 1, Baseline [Visit 2] and throughout the study).;For inclusion into TP, subjects must meet the following criteria at Baseline (Visit 2):;12. Have minimum average daily pain score as per the study protocol on the 11-point NRS pain scale (mean of the average daily pain score recorded at each of the 7 days prior to Baseline [Visit 2]).;13. Minimum number of urinary voids as per the study protocol in a 24-hour period recorded within 3 days (72 hours) prior to Baseline (Visit 2).;14. Have undergone a cystoscopy within the last 36 months (inclusive) prior to Baseline (Visit 2). For cystoscopies performed prior to Screening Visit 1, results of that cystoscopy must be available and include presence or absence of Hunner Lesion and additional pathology.;* If the cystoscopy was performed for non-
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria at Screening Visit 1 will not be eligible for study participation. However, subjects fulfilling criterion 2 will be eligible for rescreening:;1. Catastrophizing pain score over maximum score allowed per the study protocol as determined by the Pain Catastrophizing Scale (PCS).;2. Have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days (inclusive) or presence on laboratory C&S at Screening Visit 1. Subjects with current infection may be treated according to standard of care and rescreened at least 10 days after resolution of infection (and have a repeat urine C&S that was documented as clear).;3. Microscopic hematuria that has not been adequately evaluated per local standard of care.;4. History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years. ;5. Currently receiving any of the following prohibited medications or procedures:;* Taken antihistamine or NSAID unless on a stable dose for *30 days prior to Screening Visit 1. ;* Taken any long-acting opiates within 2 weeks prior to Baseline (Visit 2) and throughout the study, or more than 10 short-acting opiates/month. If (short-acting) opiate analgesics are taken during the screening period they should be limited to a maximum of 2 days per week and not within 3 days prior to randomization. ;* Oral steroid or cyclosporine therapy within 30 days prior to Screening Visit 1 and throughout the study.;* Had treatment with intravesical therapy within 60 days prior to Screening Visit 1.;* Bladder hydrodistension and/or fulguration within 3 months prior to Screening Visit 1 and throughout the study.;* Have taken any investigational drug within 90 days prior to Screening Visit 1 or have had previous exposure to AQX-1125.;6. History of previous procedure(s) (augmentation cystoplasty, cystectomy, cystolysis, botulinum toxin or bladder catheterization) that has significantly affected bladder function.;7. History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis.;8. Females: History of bladder tumors or uterine, cervical, vaginal or urethral cancer.;9. Males: History of prostate surgery (transurethral resection of the prostate [TURP], transurethral radiofrequency thermotherapy [TURT], transurethral incision of the prostate [TUIP], transurethral needle ablation [TUNA], etc.), a history of prostate cancer, or currently being treated for chronic bacterial prostatitis. ;10. 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. In case of any doubt, the Investigator shall consult the Medical Monitor.;11. Major surgery within 3 months prior to Screening Visit 1.;12. Known intolerance to micro-crystalline cellulose (Avicel® PH-102), mannitol or other ingredient of AQX-1125 tablets.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints are: * The mean change from Baseline (Visit 2) at Week 12 (Visit 4) for AQX-1125 100 mg or 200 mg compared to placebo in the following: o Voiding frequency measured over a 24-hour period, within a 3 day (72 hours) window before Baseline (Visit 2) and again before Week 12 (Visit 4). o ICSI. o BPIC-SS. * Overall response to treatment for AQX-1125 100 mg or 200 mg compared to placebo as measured by the subject*s GRA at Week 12. Safety endpoints: * The frequency and severity of AEs will be reported for the TP phase, the 52-week EP, and TP and EP combined, and will include: o Abnormal, clinically significant vital signs, laboratory tests, ECG, weight, or findings on physical examinations. * Ophthalmic examination, as defined in Section 12.6. Exploratory endpoints: * Evaluation of the proportion of subjects improving by the derived MCID in the maximum pain assessment at Week 12, for which an anchor based analysis using the GRA for anchoring will be conducted to derive the MCID. * The change from Baseline (Visit 2) at Week 6 (Visit 3) for AQX-1125 100 mg or 200 mg compared to placebo in: o Maximum daily bladder pain based on an 11-point NRS recorded by e-diary as measured by the mean of the maximum pain scores recorded once daily for a minimum of 5 of the 7 days prior to each visit. o Voiding frequency measured over a 24-hour period, within a 3-day (72 hours) window before Baseline (Visit 2) and again before Week 6 (Visit 3). o ICSI. o BPIC-SS. * Overall response to treatment for AQX-1125 100 mg or 200 mg compared to placebo as measured by the subject*s GRA at Week 6. * The change from Baseline (Visit 2) at Week 6 (Visit 3) and Week 12 (Visit 4) for AQX 1125 100 mg or 200 mg compared to placebo in the following: o ICPI. o Average daily pain based on an 11-point NRS recorded by e-diary as measured by the mean of the average pain scores recorded for a minimum of 5 of the 7 days prior to each visit. * The proport | — |
Primary
| Measure | Time frame |
|---|---|
| The change from Baseline (Visit 2) at Week 12 (Visit 4) for AQX-1125 100 mg or 200 mg compared to placebo in the maximum daily bladder pain score based on a standardized 11 point NRS recorded by e-diary as measured by the mean of the maximum scores recorded once daily for a minimum of 5 of the 7 days prior to each visit. | — |
Countries
Belgium, Canada, Czechia, Denmark, Hungary, Latvia, Netherlands, Poland, Romania, Spain, United Kingdom, United States of America
Outcome results
None listed