Clinical Trial: A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study Evaluating The Efficacy And Safety Of Tanezumab For The Treatment Of Moderate To Severe Pain Associated With Same as current
Current Secondary Outcome:
- 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 ]
- 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 ]
- 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 ]
- Patient Global Assessment [ Time Frame: 24 weeks ]
- Global Response Assessment [ Time Frame: 24 weeks ]
- Micturition frequency per 24 hours, including nocturnal frequency [ Time Frame: 24 weeks ]
- Micturition urgency frequency per 24 hours [ Time Frame: 24 weeks ]
- Urge to urinate [ Time Frame: 24 weeks ]
- Mean volume voided per micturition [ Time Frame: 24 weeks ]
- O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 24 weeks ]
- Brief Pain Inventory (BPI) [ Time Frame: 24 weeks ]
- Patient Reported Treatment Impact (PRTI) [ Time Frame: 24 weeks ]
- EQ5D questionnaire [ Time Frame: 24 weeks ]
- Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) [ Time Frame: 24 weeks ]
- Rescue medication use [ Time Frame: 24 weeks ]
- Biomarkers for Interstitial Cystitis/Painful bladder syndrome [ Time Frame: 24 weeks ]
- Physical examination, including SC injection site. [ Time Frame: 24 weeks ]
- Neurological examination and Neuropathy Impairment Score (NIS). [ Time Frame: 24 weeks ]
- Vital signs (temperature, blood pressure, heart rate and respiratory rate). [ Time Frame: 24 weeks ]
- Weight. [ Time Frame: 24 weeks ]
- ECG [ Time Frame: 24 weeks ]
- Post void residum (PVR) volume assessment using trans-abdominal ultrasound [ Time Frame: 24 weeks ]
- Pregnancy testing [ Time Frame: 24 weeks ]
- Urinalysis [ Time Frame: 24 weeks ]
- Clinical laboratory assessments [ Time Frame: 24 weeks ]
- Anti-Drug Antibody (ADA; anti-bodies against tanezumab). [ Time Frame: 24 weeks ]
- Adverse events from time of Screening through the last clinic visit. [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: October 20, 2009
Date Started: January 2010
Date Completion:
Last Updated: August 23, 2012
Last Verified: August 2012