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
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:
Cystitis
Pain
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014