Secondary Outcome(s)
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Pregnancy testing
[Time Frame: 24 weeks]
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ECG
[Time Frame: 24 weeks]
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Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL)
[Time Frame: 24 weeks]
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Brief Pain Inventory (BPI)
[Time Frame: 24 weeks]
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Micturition urgency frequency per 24 hours
[Time Frame: 24 weeks]
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Physical examination, including SC injection site.
[Time Frame: 24 weeks]
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Rescue medication use
[Time Frame: 24 weeks]
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Biomarkers for Interstitial Cystitis/Painful bladder syndrome
[Time Frame: 24 weeks]
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Clinical laboratory assessments
[Time Frame: 24 weeks]
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Change from Baseline in mean average daily pain over 7 days at other timepoints throughout the study as measured by an 11-point Numeric Rating Scale (NRS)
[Time Frame: 24 weeks]
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Global Response Assessment
[Time Frame: 24 weeks]
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Treatment Response: Reduction of =30% and =50% in mean average daily pain score from Baseline at various time points through the study
[Time Frame: 24 weeks]
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Change from Baseline in mean worst daily pain over 7 days as measured by an 11-point Numeric Rating Scale (NRS)
[Time Frame: 24 weeks]
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Micturition frequency per 24 hours, including nocturnal frequency
[Time Frame: 24 weeks]
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Neurological examination and Neuropathy Impairment Score (NIS).
[Time Frame: 24 weeks]
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Post void residum (PVR) volume assessment using trans-abdominal ultrasound
[Time Frame: 24 weeks]
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Weight.
[Time Frame: 24 weeks]
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Adverse events from time of Screening through the last clinic visit.
[Time Frame: 24 weeks]
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EQ5D questionnaire
[Time Frame: 24 weeks]
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Patient Global Assessment
[Time Frame: 24 weeks]
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Mean volume voided per micturition
[Time Frame: 24 weeks]
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Urge to urinate
[Time Frame: 24 weeks]
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Anti-Drug Antibody (ADA; anti-bodies against tanezumab).
[Time Frame: 24 weeks]
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O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score
[Time Frame: 24 weeks]
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Patient Reported Treatment Impact (PRTI)
[Time Frame: 24 weeks]
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Urinalysis
[Time Frame: 24 weeks]
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Vital signs (temperature, blood pressure, heart rate and respiratory rate).
[Time Frame: 24 weeks]
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