A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00999518
First received: October 20, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels


Condition Intervention Phase
Cystitis, Interstitial
Biological: Tanezumab
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Interstitial Cystitis/ Painful Bladder Syndrome (IC/PBS)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patient Global Assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Global Response Assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Micturition frequency per 24 hours, including nocturnal frequency [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Micturition urgency frequency per 24 hours [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Urge to urinate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean volume voided per micturition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory (BPI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • EQ5D questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Biomarkers for Interstitial Cystitis/Painful bladder syndrome [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physical examination, including SC injection site. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Neurological examination and Neuropathy Impairment Score (NIS). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs (temperature, blood pressure, heart rate and respiratory rate). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Weight. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Post void residum (PVR) volume assessment using trans-abdominal ultrasound [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Pregnancy testing [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Urinalysis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory assessments [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Anti-Drug Antibody (ADA; anti-bodies against tanezumab). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events from time of Screening through the last clinic visit. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Tanezumab
1 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 2 Biological: Tanezumab
2.5 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 3 Biological: Tanezumab
10 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 4 Biological: Tanezumab
20 mg dose given subcutaneously twice at an 8-week interval.
Placebo Comparator: Group 5 Other: Placebo
Placebo dose given subcutaneously twice at an 8-week interval.

Detailed Description:

This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999518

  Show 134 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00999518     History of Changes
Other Study ID Numbers: A4091035
Study First Received: October 20, 2009
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014