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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739739
First Posted: August 22, 2008
Last Update Posted: March 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [ Time Frame: 12 WEEKS ]

Secondary Outcome Measures:
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ]
  • ICSI at other time points [ Time Frame: 12 weeks ]
  • Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 12 weeks ]
  • Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 12 Weeks ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 Weeks ]
  • Adverse events [ Time Frame: 15 Weeks ]
  • Physical examination [ Time Frame: 14 Weeks ]
  • Vital signs and weight [ Time Frame: 15 Weeks ]
  • ECG [ Time Frame: 14 Weeks ]
  • Residual urine volume measurement [ Time Frame: 14 Weeks ]
  • Global Response assessment (GRA) [ Time Frame: 12 Weeks ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: 12 Weeks ]
  • Treatment failures [ Time Frame: 12 Weeks ]
  • Average and worst daily pain score at other time points as measured by an 11-point NRS. [ Time Frame: 12 Weeks ]
  • Sleep disturbance and sexual activity pain. [ Time Frame: 12 Weeks ]
  • Clinical laboratory tests [ Time Frame: 14 Weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739739


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

Additional Information:
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
First Submitted: August 20, 2008
First Posted: August 22, 2008
Last Update Posted: March 28, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Syndrome
Pain
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases