Clinical Trial: An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof Of Concept Study Evaluating The Efficacy And Safety Of PF-04383119 For The Treatment Of Pain Associat

Brief Summary: The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Change in average daily pain [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ]
  • Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ]
  • Global response assessment [ Time Frame: 16 weeks ]
  • Patient-reported treatment impact assessment [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]
  • Biomarkers [ Time Frame: 16 weeks ]
  • Safety endpoints [ Time Frame: 16 weeks ]
  • Pharmacokinetic measures [ Time Frame: 16 weeks ]
  • Change in average daily pain [ Time Frame: 16 weeks ]
  • Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ]


Original Secondary Outcome:

  • Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ]
  • Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ]
  • Global response assessment [ Time Frame: 16 weeks ]
  • Patient-reported treatment impact assessment [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]
  • Biomarkers [ Time Frame: 16 weeks ]
  • Safety endpoints [ Time Frame: 16 weeks ]
  • Pharmacokinetic measures [ Time Frame: 16 weeks ]
  • Change in average daily pain [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ]


Information By: Pfizer

Dates:
Date Received: January 15, 2008
Date Started: March 2008
Date Completion:
Last Updated: January 4, 2011
Last Verified: January 2011