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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Interstitial Cystitis; Painful Bladder Syndrome

Treatments: Drug: PD 0299685 at 15mg BID; Drug: PD 0299685 at 30mg BID; Drug: placebo for PD 0299685

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739739

A4291043

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 3 patient groups, including a placebo group

PD 0299685 15mg

Experimental group

Treatment:

Drug: PD 0299685 at 15mg BID

PD 0299685 30mg

Experimental group

Treatment:

Drug: PD 0299685 at 30mg BID

Placebo

Placebo Comparator group

Treatment:

Drug: placebo for PD 0299685