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NCT Number: NCT00479505

Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Miranda, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male subjects aged 18 years and above
  • documented clinical diagnosis of overactive bladder with urinary frequency >= 8 times / 24 hours and number of urgency episodes > 1 episode / 24 hours.

Exclusion criteria

  • Neurological diseases known to affect bladder function.
  • Urinary tract infection.

Treatment and study plan

UK-369,003

Drug

UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.

Placebo

Drug

Placebo

Primary outcomes

  1. This is an estimation study with no primary endpoint. There are efficacy endpoints.

    Time frame: 12 Weeks

Secondary outcomes

  1. Patient reported treatment impact questionnaire.

    Time frame: 12 Weeks

  2. Lower urinary tract symptoms diary.

    Time frame: 12 Weeks

  3. International prostate symptom score questionnaire.

    Time frame: 12 Weeks

  4. OAB-q short form questionnaire.

    Time frame: 12 Weeks

  5. Patient perception of bladder control questionnaire.

    Time frame: 12 Weeks

  6. International index of erectile function questionnaire.

    Time frame: 12 Weeks

  7. International consultation on incontinence questionnaire.

    Time frame: 12 Weeks

  8. Quality of erection questionnaire.

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 28, 2007
Registry last updated
Mar 23, 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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