August 20, 2008 |
May 11, 2009 |
August 2008 |
- 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 ]
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Same as current |
Complete list of historical versions of study NCT00739739 on ClinicalTrials.gov Archive Site |
- 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 ]
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- Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- ICSI at other time points, Interstitial Cytstitis Problem Index (ICPI), and Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Physical examination, vital signs and weight, ECG, residual urine volume measurement, Clinical laboratory tests
• Epworth Sleepiness Scale (ESS).
• Columbia-Suicide Severity Rating Scale (C-SSRS).
• Adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
- Average and worst daily pain score at other time points as measured by an 11-point NRS. Sleep disturbance and sexual activity pain. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Global Response assessment (GRA), Patient Reported Treatment Impact (PRTI), and treatment failures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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An Effectiveness and Safety Study of PD 0299685 for the Treatment of Symptoms Associated With Interstitial Cystitis |
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. |
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. |
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Phase II |
Interventional |
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
- Interstitial Cystitis
- Painful Bladder Syndrome
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- Drug: PD 0299685 at 15mg BID
- Drug: PD 0299685 at 30mg BID
- Drug: placebo for PD 0299685
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Recruiting |
129 |
September 2009 |
September 2009 (final data collection date for primary outcome measure) |
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
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Both |
18 Years and older |
No |
Contact: Pfizer CT.gov Call Center |
1-800-718-1021 |
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United States, Canada, Denmark, Finland, France, Germany |
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NCT00739739 |
Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
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Pfizer |
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Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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Pfizer |
May 2009 |