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

NCT00479505 | Completed Phase 2

• 1 other identifier: A3711047
• Study Type: interventional
• Target: 275
• Locations: 16 countries
• Sites: 52

Brief Summary

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.

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

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

  12 Weeks

Secondary Outcomes (8)

• Patient reported treatment impact questionnaire.

  12 Weeks

• Lower urinary tract symptoms diary.

  12 Weeks

• International prostate symptom score questionnaire.

  12 Weeks

• OAB-q short form questionnaire.

  12 Weeks

• Patient perception of bladder control questionnaire.

  12 Weeks

Study Arms (2)

Active

EXPERIMENTAL

Drug: UK-369,003

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

UK-369,003 DRUG

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

Active

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Pfizer Investigational Site

Miranda, New South Wales, 2228, Australia

Location

Pfizer Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

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Victoria, British Columbia, V8T 5G1, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Kitchener, Ontario, N2N 2B9, Canada

Location

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Toronto, Ontario, M6A 3B5, Canada

Location

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Rancagua, Región del Libertador General Bernardo O’Higgins, 2820945, Chile

Location

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Santiago, RM, 8380419, Chile

Location

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Santiago, RM, 8380456, Chile

Location

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Medellín, Antioquia, 0, Colombia

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Bogota, Cundinamarca, Colombia

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Helsinki, 00100, Finland

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Kouvola, 45200, Finland

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Oulu, 90100, Finland

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Tampere, 33100, Finland

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Turku, 20100, Finland

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Garches, 92380, France

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Lyon, 69437, France

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Montpellier, 34090, France

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Paris, 75020, France

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Rennes, 35033, France

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Frankfurt, 65929, Germany

Location

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Marburg, 35039, Germany

Location

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Muelheim A.d. Ruhr, 45468, Germany

Location

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München, 81925, Germany

Location

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Rosenheim, 83022, Germany

Location

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Cholargós, Athens, 15562, Greece

Location

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Epirus, Ioannina, 45500, Greece

Location

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Rio, Patras, 26500, Greece

Location

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Cefalù, Palermo, 90015, Italy

Location

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Florence, 50139, Italy

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Latina, 04100, Italy

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Riga, LV 1010, Latvia

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Moelv, N-2390, Norway

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Oslo, NO-0257, Norway

Location

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Mysłowice, 41-400, Poland

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Poznan, 61-485, Poland

Location

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Szczecin, 70-111, Poland

Location

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Szczecin, 70-451, Poland

Location

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Szczecin, 70-467, Poland

Location

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Wroclaw, 53-020, Poland

Location

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Bratislava, Slovakia, 833 31, Slovakia

Location

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Martin, Slovakia, 036 59, Slovakia

Location

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Trenčín, Slovakia, 911 01, Slovakia

Location

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Košice, 040 11, Slovakia

Location

Pfizer Investigational Site

Sabadell, Barcelona, 08208, Spain

Location

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Manacor, Palma de Mallorca, 07500, Spain

Location

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Aarau, 5001, Switzerland

Location

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Zurich, 8091, Switzerland

Location

Pfizer Investigational Site

High Heaton, Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Pfizer Investigational Site

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

PL (6); CA (4); AU (2); CO (2); NO (2); DE (5); GB (3); ES (2); GR (3); LA (1); FR (5); SL (4); CL (3); FI (5); IT (3); CH (2)