Detrol LA In Men With Overactive Bladder.

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00282932

Collaborator

(none)

600

Enrollment

Locations

16.4

Duration (Months)

7.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder (OAB)	Drug: Detrol LA	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 14, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Anaheim	California	United States	92801
2	Pfizer Investigational Site	La Mesa	California	United States	91942
3	Pfizer Investigational Site	Aurora	Colorado	United States	80012
4	Pfizer Investigational Site	Iowa City	Iowa	United States	52242-1089
5	Pfizer Investigational Site	Shreveport	Louisiana	United States	71106
6	Pfizer Investigational Site	Watertown	Massachusetts	United States	02472
7	Pfizer Investigational Site	Westampton	New Jersey	United States	08060
8	Pfizer Investigational Site	New York	New York	United States	10016
9	Pfizer Investigational Site	Cincinnati	Ohio	United States	45212
10	Pfizer Investigational Site	State College	Pennsylvania	United States	16801
11	Pfizer Investigational Site	Houston	Texas	United States	77024
12	Pfizer Investigational Site	Calgary	Alberta	Canada	T2V 4R6
13	Pfizer Investigational Site	Surrey	British Columbia	Canada	V3V 1N1
14	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8T5G1
15	Pfizer Investigational Site	Kingston	Ontario	Canada	K7L 3J7
16	Pfizer Investigational Site	London	Ontario	Canada	N6A 4V2
17	Pfizer Investigational Site	Oakville	Ontario	Canada	L6H 3P1
18	Pfizer Investigational Site	Toronto	Ontario	Canada	M4N 3M5
19	Pfizer Investigational Site	Toronto	Ontario	Canada	M5T 2S8
20	Pfizer Investigational Site	Toronto	Ontario	Canada	M6A 3B5
21	Pfizer Investigational Site	Montreal	Quebec	Canada	H2X 1N8
22	Pfizer Investigational Site	Montreal	Quebec	Canada	H3S 1Z1
23	Pfizer Investigational Site	Pointe-Claire	Quebec	Canada	H9R 4S3
24	Pfizer Investigational Site	Aalborg		Denmark	9100
25	Pfizer Investigational Site	Herlev		Denmark	DK-2730
26	Pfizer Investigational Site	Nykobing Falster		Denmark	4800
27	Pfizer Investigational Site	Berlin		Germany	13347
28	Pfizer Investigational Site	Duisburg		Germany	47179
29	Pfizer Investigational Site	Frankfurt		Germany	65929
30	Pfizer Investigational Site	Muelheim A.d. Ruhr		Germany	45468
31	Pfizer Investigational Site	Muenchen		Germany	81369
32	Pfizer Investigational Site	Muenchen		Germany	81925
33	Pfizer Investigational Site	Rosenheim		Germany	83022
34	Pfizer Investigational Site	Starnberg		Germany	82319
35	Pfizer Investigational Site	Latina		Italy	04100
36	Pfizer Investigational Site	Padova		Italy	35128
37	Pfizer Investigational Site	Bucheon-si	Gyunggi-do	Korea, Republic of	420-717
38	Pfizer Investigational Site	Busan		Korea, Republic of	602-739
39	Pfizer Investigational Site	Seoul		Korea, Republic of	135-270
40	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
41	Pfizer Investigational Site	Guadalajara	Jalisco	Mexico	44100
42	Pfizer Investigational Site	Zapopan	Jalisco	Mexico	45200
43	Pfizer Investigational Site	Tlalpan	México DF	Mexico	14000
44	Pfizer Investigational Site	Durango		Mexico	34000
45	Pfizer Investigational Site	Durango		Mexico	34079
46	Pfizer Investigational Site	Bodø		Norway	8087
47	Pfizer Investigational Site	Moelv		Norway	2391
48	Pfizer Investigational Site	Bratislava		Slovakia	833 05
49	Pfizer Investigational Site	Kosice		Slovakia	040 11
50	Pfizer Investigational Site	Malacky		Slovakia	901 01
51	Pfizer Investigational Site	Martin		Slovakia	036 01
52	Pfizer Investigational Site	Skalica		Slovakia	909 82
53	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9300
54	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9301
55	Pfizer Investigational Site	Parktown	Gauteng Province	South Africa	2193
56	Pfizer Investigational Site	Durban	Kwa Zulu Natal	South Africa	4001
57	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal	South Africa	3201
58	Pfizer Investigational Site	Cape Town		South Africa	8001
59	Pfizer Investigational Site	A Coruna	A Coruña	Spain	15006
60	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares	Spain	07014
61	Pfizer Investigational Site	Barcelona		Spain	08025
62	Pfizer Investigational Site	Granada		Spain	18014
63	Pfizer Investigational Site	Madrid		Spain	28016
64	Pfizer Investigational Site	Madrid		Spain	28040
65	Pfizer Investigational Site	Valencia		Spain	46009
66	Pfizer Investigational Site	Boras		Sweden	503 32
67	Pfizer Investigational Site	Huskvarna		Sweden	561 36
68	Pfizer Investigational Site	Lund		Sweden	221 85
69	Pfizer Investigational Site	Skovde		Sweden	541 30
70	Pfizer Investigational Site	Hualien		Taiwan	970
71	Pfizer Investigational Site	Kaohsiung		Taiwan	833
72	Pfizer Investigational Site	Taipei		Taiwan	100
73	Pfizer Investigational Site	Taipei		Taiwan
74	Pfizer Investigational Site	Adana		Turkey	01230
75	Pfizer Investigational Site	Istanbul		Turkey
76	Pfizer Investigational Site	Izmir		Turkey	35100
77	Pfizer Investigational Site	Sihhiye-Ankara		Turkey
78	Pfizer Investigational Site	Bristol	Avon	United Kingdom	BS10 5NB
79	Pfizer Investigational Site	Crewe	Cheshire	United Kingdom	CW1 4QJ
80	Pfizer Investigational Site	Taunton	Somerset	United Kingdom	TA1 5DA
81	Pfizer Investigational Site	London		United Kingdom	N19 5LW

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00282932

Other Study ID Numbers:

A6121127

First Posted:

Jan 27, 2006

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Tolterodine Tartrate

Study Results

No Results Posted as of Jan 27, 2021