E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bladder Pain Syndrome / Interstitial Cystitis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain in bladder and pelvic area |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071166 |
E.1.2 | Term | Bladder pain syndrome |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008928 |
E.1.2 | Term | Chronic interstitial cystitis NOS |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008927 |
E.1.2 | Term | Chronic interstitial cystitis |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011796 |
E.1.2 | Term | Cystitis interstitial |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate efficacy of ASP3652 in female subjects with BPS/IC |
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E.2.2 | Secondary objectives of the trial |
To assess the optimal dose of ASP3652 for the treatment of female subjects with BPS/IC.
To investigate safety and tolerability of ASP3652 in female subjects with BPS/IC.
To investigate the PK and PD of ASP3652 in female subjects with BPS/IC.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At Visit 1:
1. Written informed consent has been obtained. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Is female, 18 years of age or older and of Caucasian (white) ethnic background.
3. Has previously been diagnosed with BPS/IC; i.e, pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes.
4. Has a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F GUPI.
5. Must practice a highly reliable method of birth control. When of childbearing potential, subjects must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs), sexual abstinence or vasectomized partner.
6. Is willing and able to comply with study requirements (e.g, complete questionnaires and diaries) and attend all required study visits.
At randomization (Visit 2/BV), the subject
7. Is confirmed to have at least moderate pain as reflected by a MDP of at least 4.0. The MDP is the mean of 7 consecutive daily assessments of average pain on an 11 point (0-10) NRS with a recall period of 24 hours (item 4 of F GUPI-24h).
8. Is confirmed to be willing to comply and has shown to be compliant with study requirements (such as completing questionnaires and diaries, compliance with study drug use and practicing a highly reliable method of birth control) and with attending all study visits.
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E.4 | Principal exclusion criteria |
1. A positive pregnancy test (-HCG in serum) or be lactating.#
2. Undergone a CS with hydrodistension or undergone Botox injections in the bladder within 6 months prior to the screening visit.
3. Been treated with pentosan polysulphate sodium within 4 weeks prior to the screening visit.
4. Had any intravesicular pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide [DMSO]), or have had other interventions for BPS/IC (including electric stimulation therapy or acupuncture therapy) that may have affected disease symptoms within 3 months prior to the screening visit.
5. Cystitis (radiation cystitis, Bacillus Calmette-Guérin (BCG)-induced cystitis, bacterial / tuberculous cystitis, cyclophosphamide cystitis) or had a documented symptomatic bacterial cystitis in the last 3 months prior to the screening visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline (last week of Run-in) in MDP at week 12 (the week prior to Visit 6/EoT). MDP is the mean of 7 consecutive daily assessments of pain. Pain is assessed on an 11 point (0-10) NRS with a recall period of 24 hours, which is item 4 of the F-GUPI-24h as recorded by the subject in the electronic diary. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
week 0, week 4, week 8, week 12, (week 14) |
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E.5.2 | Secondary end point(s) |
Change from baseline (Visit 2/BV) in F-GUPI Total score at week 12 (Visit 6/EoT). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week 0, week 4, week 8, week 12, (week 14) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Czech Republic |
Denmark |
France |
Germany |
Latvia |
Netherlands |
Poland |
Portugal |
Romania |
Russian Federation |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |