An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00739739
First received: August 20, 2008
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.


Condition Intervention Phase
Interstitial Cystitis
Painful Bladder Syndrome
Drug: PD 0299685 at 15mg BID
Drug: PD 0299685 at 30mg BID
Drug: placebo for PD 0299685
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 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
  • Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ICSI at other time points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Vital signs and weight [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Residual urine volume measurement [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Global Response assessment (GRA) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Treatment failures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Average and worst daily pain score at other time points as measured by an 11-point NRS. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sleep disturbance and sexual activity pain. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: August 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD 0299685 15mg Drug: PD 0299685 at 15mg BID
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
Experimental: PD 0299685 30mg Drug: PD 0299685 at 30mg BID
10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
Placebo Comparator: Placebo Drug: placebo for PD 0299685
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
  • Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Exclusion Criteria:

  • History of interstitial cystitis less than 6 months
  • History of current or recurrent urinary tract infections, or genitourinary cancer
  • Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
  • Use of certain drugs given into the bladder up to 1 month prior to study entry
  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: NCT00739739

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00739739     History of Changes
Other Study ID Numbers: A4291043
Study First Received: August 20, 2008
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014