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

Phase 2

Completed

• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Drug: placebo for PD 0299685; Drug: PD 0299685 at 15mg BID; Drug: PD 0299685 at 30mg BID

• Registration Number: NCT00739739
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-22
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-03
• Disposition First Submitted: 2011-03-16
• Disposition First Submitted QC: 2011-03-16
• Last Update Submitted: 2011-03-16
• Disposition First Posted: 2011-03-28
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo for PD 0299685	-
PD 0299685 15mg	PD 0299685 at 15mg BID	-
PD 0299685 30mg	PD 0299685 at 30mg BID	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.	12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).	12 WEEKS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Muenchen, Germany