E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed with Bladder Pain Syndrome (BPS) |
|
E.1.1.1 | Medical condition in easily understood language |
Patients diagnosed with Bladder Pain Syndrome (BPS) |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
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 the symptomatic effect of treatment with Kineret for BPS |
|
E.2.2 | Secondary objectives of the trial |
Investigate the molecular mechanisms resulting in BPS Investigate the molecular effects of Kineret in patients with BPS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosed BPS • Signed written informed consent form • Capability and willingness to comply with study procedures • Adult patients ≥ 18 – 65 years • Negative urine pregnancy test in women of childbearing potential • Sum score in symptom score measured by the O’Leary during the treatment |
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E.4 | Principal exclusion criteria |
• Malignant medical history • Immunosuppression • Diabetes Mellitus • Neutropenia (<1,5x109/L) • Lactation • Age < 18 years • Anamnestic exclusion of patients with active severe infections, history of viral hepatitis. • Patients using CYP450 medications (e.g. Warfarin, Phenytoin) • Patients using Phenytoin medication • Anamnestic exclusion of patients with a history of tuberculosis or active tuberculosis (only anamnestic exclusion possible, as immediate inclusion in the study is urgently required for this disease pattern • Serological blood test results (processing time ≥ 24 hours) • Extragenital conditions, nephrological conditions, urological conditions • Known allergies/contraindications to Kineret • Malignant diseases • Immunosuppression • Previously enrolled in this trial • Pathological liver enzymes • Polyneuropathies • Glucose-6-phosphate dehydrogenase deficiency • Participation in other interventional clinical trials • Use of Diclofenac and Ibuprofen analgetic medication while participating in this clinical trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in symptom score measured by the O’Leary during the treatment period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the first screening phase (Visit 1 on Day 1, Visit 2 on Day 7, Visit 3 in Week 4) followed by phase 2 (Visit 4 in Week 6, Visit 5 in Week 8, Visit 6 in Week 10, Visit 7 in Week 12). |
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E.5.2 | Secondary end point(s) |
Safety: Adverse event, treatment emergent adverse events, serious adverse events
Secondary: Reduction of urinary levels of substance P |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety: Baseline throughout the trial
Secondary: Reduction of urinary levels of substance P measured at each visit |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Urine proteomics, Gene expression analysis, DNA sequence analysis
|
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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 | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |