Detrol LA In Men With Overactive Bladder.

NCT ID: NCT00282932

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-05-14

Brief Summary

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An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.

Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).

Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

Detailed Description

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Conditions

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Overactive Bladder (OAB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Detrol LA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)

Exclusion Criteria

* Significant hepatic or renal disease, history of radiation treatment
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Anaheim, California, United States

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La Mesa, California, United States

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Aurora, Colorado, United States

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Iowa City, Iowa, United States

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Shreveport, Louisiana, United States

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Watertown, Massachusetts, United States

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Woodlane, New Jersey, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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State College, Pennsylvania, United States

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Houston, Texas, United States

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Calgary, Alberta, Canada

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Aalborg, , Denmark

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Herlev, , Denmark

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Nykøbing Falster, , Denmark

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Berlin, , Germany

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Duisburg, , Germany

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Frankfurt, , Germany

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Muelheim A.d. Ruhr, , Germany

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München, , Germany

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München, , Germany

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Rosenheim, , Germany

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Starnberg, , Germany

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Latina, , Italy

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Padua, , Italy

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Tlalpan, México DF, Mexico

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Durango, , Mexico

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Durango, , Mexico

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Bodø, , Norway

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Moelv, , Norway

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Bratislava, , Slovakia

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Košice, , Slovakia

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Malacky, , Slovakia

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Martin, , Slovakia

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Skalica, , Slovakia

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Bloemfontein, Free State, South Africa

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Bloemfontein, Free State, South Africa

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Parktown, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Pietermaritzburg, KwaZulu-Natal, South Africa

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Cape Town, , South Africa

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Bucheon-si, Gyunggi-do, South Korea

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Busan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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A Coruña, A Coruña, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Borås, , Sweden

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Huskvarna, , Sweden

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Lund, , Sweden

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Skövde, , Sweden

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Hualien City, , Taiwan

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Adana, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Sihhiye-Ankara, , Turkey (Türkiye)

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Bristol, Avon, United Kingdom

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Crewe, Cheshire, United Kingdom

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Taunton, Somerset, United Kingdom

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London, , United Kingdom

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Countries

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United States Canada Denmark Germany Italy Mexico Norway Slovakia South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

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Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.

Reference Type DERIVED
PMID: 19070418 (View on PubMed)

Related Links

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Other Identifiers

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A6121127

Identifier Type: -

Identifier Source: org_study_id

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