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Detrol LA In Men With Overactive Bladder.

Primary Purpose

Overactive Bladder (OAB)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Detrol LA
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder (OAB)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Patient Perception of Bladder Condition at 12 weeks of treatment

Secondary Outcome Measures

1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
incontinence.

Full Information

First Posted
January 26, 2006
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00282932
Brief Title
Detrol LA In Men With Overactive Bladder.
Official Title
A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 1, 2007 (Actual)
Study Completion Date
May 14, 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder (OAB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Detrol LA
Primary Outcome Measure Information:
Title
Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary Outcome Measure Information:
Title
1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
Title
assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
Title
Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
Title
f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
Title
Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
Title
incontinence.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1089
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Pfizer Investigational Site
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Pfizer Investigational Site
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T5G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Nykobing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Pfizer Investigational Site
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muelheim A.d. Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81369
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Pfizer Investigational Site
City
Starnberg
ZIP/Postal Code
82319
Country
Germany
Facility Name
Pfizer Investigational Site
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bucheon-si
State/Province
Gyunggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-270
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Tlalpan
State/Province
México DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Durango
ZIP/Postal Code
34079
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Bodø
ZIP/Postal Code
8087
Country
Norway
Facility Name
Pfizer Investigational Site
City
Moelv
ZIP/Postal Code
2391
Country
Norway
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Malacky
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Gauteng Province
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pietermaritzburg
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
A Coruna
State/Province
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Boras
ZIP/Postal Code
503 32
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Huskvarna
ZIP/Postal Code
561 36
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Skovde
ZIP/Postal Code
541 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Sihhiye-Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Crewe
State/Province
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
N19 5LW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19070418
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121127&StudyName=Detrol%20LA%20In%20Men%20With%20Overactive%20Bladder.%0D
Description
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Detrol LA In Men With Overactive Bladder.

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