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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00999518
Date of registration: 20/10/2009
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Scientific 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 INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).
Date of first enrolment: January 22, 2010
Target sample size: 205
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00999518
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Belgium Canada Finland Germany Hong Kong India Japan Korea, Republic of
Poland Romania Russian Federation Slovakia South Africa Spain Sweden Taiwan
United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months
with moderate to severe pain and a micturition frequency greater than 7 per day.

- Patients who have been on stable oral medicines for interstitial cystitis/ painful
bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

- Patients on certain recent treatments for interstitial cystitis/ painful bladder
syndrome.

- Body mass index (BMI) of >39 kg/m2.

- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG-fusion protein.

- Patients with peripheral neuropathy.

- Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystitis, Interstitial
Intervention(s)
Other: Placebo
Biological: Tanezumab
Primary Outcome(s)
The primary endpoint is change from Baseline in mean average daily pain over 7 days at Week 16 as measured by an 11-point Numeric Rating Scale (NRS). [Time Frame: 24 weeks]
Secondary Outcome(s)
Pregnancy testing [Time Frame: 24 weeks]
ECG [Time Frame: 24 weeks]
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) [Time Frame: 24 weeks]
Brief Pain Inventory (BPI) [Time Frame: 24 weeks]
Micturition urgency frequency per 24 hours [Time Frame: 24 weeks]
Physical examination, including SC injection site. [Time Frame: 24 weeks]
Rescue medication use [Time Frame: 24 weeks]
Biomarkers for Interstitial Cystitis/Painful bladder syndrome [Time Frame: 24 weeks]
Clinical laboratory assessments [Time Frame: 24 weeks]
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]
Global Response Assessment [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]
Micturition frequency per 24 hours, including nocturnal frequency [Time Frame: 24 weeks]
Neurological examination and Neuropathy Impairment Score (NIS). [Time Frame: 24 weeks]
Post void residum (PVR) volume assessment using trans-abdominal ultrasound [Time Frame: 24 weeks]
Weight. [Time Frame: 24 weeks]
Adverse events from time of Screening through the last clinic visit. [Time Frame: 24 weeks]
EQ5D questionnaire [Time Frame: 24 weeks]
Patient Global Assessment [Time Frame: 24 weeks]
Mean volume voided per micturition [Time Frame: 24 weeks]
Urge to urinate [Time Frame: 24 weeks]
Anti-Drug Antibody (ADA; anti-bodies against tanezumab). [Time Frame: 24 weeks]
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [Time Frame: 24 weeks]
Patient Reported Treatment Impact (PRTI) [Time Frame: 24 weeks]
Urinalysis [Time Frame: 24 weeks]
Vital signs (temperature, blood pressure, heart rate and respiratory rate). [Time Frame: 24 weeks]
Secondary ID(s)
A4091035
2009-014597-17
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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