| January 15, 2008 |
| May 18, 2009 |
| March 2008 |
| April 2009 (final data collection date for primary outcome measure) |
| Change in average daily pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00601484 on ClinicalTrials.gov Archive Site |
- Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Global response assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Patient-reported treatment impact assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Biomarkers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Safety endpoints [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetic measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in average daily pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis |
| 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 Associated With Interstitial Cystitis |
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Cystitis, Interstitial |
- Drug: PF-04383119
- Drug: Placebo
|
| |
| |
| |
| Completed |
| 65 |
| April 2009 |
| April 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male and female adults at least 18 years of age;
- Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
Exclusion Criteria:
- Less than 6 months since onset of interstitial cystitis symptoms;
- History of recurrent urinary tract infections, or genitourinary cancer;
- History of hepatitis B, C or human immunodeficiency virus (HIV);
- Use of certain drugs given into the bladder up to 1 month prior to study entry.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00601484 |
| Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| A4091010 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| May 2009 |
