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Completed

NCT Number: NCT00739739

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

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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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Painful Bladder Syndrome Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD 0299685 at 15mg BID

Drug

5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study

PD 0299685 at 30mg BID

Drug

10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.

placebo for PD 0299685

Drug

Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study

Primary outcomes

  1. Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.

    Time frame: 12 WEEKS

  2. Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).

    Time frame: 12 WEEKS

Secondary outcomes

  1. Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.

    Time frame: 12 weeks

  2. ICSI at other time points

    Time frame: 12 weeks

  3. Interstitial Cystitis Problem Index (ICPI)

    Time frame: 12 weeks

  4. Pelvic pain Urgency Frequency score (PUF)

    Time frame: 12 weeks

  5. Epworth Sleepiness Scale (ESS)

    Time frame: 12 Weeks

  6. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: 15 Weeks

  7. Adverse events

    Time frame: 15 Weeks

  8. Physical examination

    Time frame: 14 Weeks

  9. Vital signs and weight

    Time frame: 15 Weeks

  10. ECG

    Time frame: 14 Weeks

  11. Residual urine volume measurement

    Time frame: 14 Weeks

  12. Global Response assessment (GRA)

    Time frame: 12 Weeks

  13. Patient Reported Treatment Impact (PRTI)

    Time frame: 12 Weeks

  14. Treatment failures

    Time frame: 12 Weeks

  15. Average and worst daily pain score at other time points as measured by an 11-point NRS.

    Time frame: 12 Weeks

  16. Sleep disturbance and sexual activity pain.

    Time frame: 12 Weeks

  17. Clinical laboratory tests

    Time frame: 14 Weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 22, 2008
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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