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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00479505
• Collaborator: (none)
• Enrollment: 275
• Locations: 52
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Drug: UK-369,003; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 275 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official 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).
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: UK-369,003; UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. This is an estimation study with no primary endpoint. There are efficacy endpoints. [12 Weeks]

Secondary Outcome Measures

1. Patient reported treatment impact questionnaire. [12 Weeks]

2. Lower urinary tract symptoms diary. [12 Weeks]

3. International prostate symptom score questionnaire. [12 Weeks]

4. OAB-q short form questionnaire. [12 Weeks]

5. Patient perception of bladder control questionnaire. [12 Weeks]

6. International index of erectile function questionnaire. [12 Weeks]

7. International consultation on incontinence questionnaire. [12 Weeks]

8. Quality of erection questionnaire. [12 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Miranda	New South Wales	Australia	2228
2	Pfizer Investigational Site	Kippa Ring	Queensland	Australia	4021
3	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8T 5G1
4	Pfizer Investigational Site	Barrie	Ontario	Canada	L4M 7G1
5	Pfizer Investigational Site	Kitchener	Ontario	Canada	N2N 2B9
6	Pfizer Investigational Site	Toronto	Ontario	Canada	M6A 3B5
7	Pfizer Investigational Site	Santiago	RM	Chile	8380419
8	Pfizer Investigational Site	Santiago	RM	Chile	8380456
9	Pfizer Investigational Site	Rancagua	VI Región	Chile	2820945
10	Pfizer Investigational Site	Medellin	Antioquia	Colombia	0
11	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
12	Pfizer Investigational Site	Helsinki		Finland	00100
13	Pfizer Investigational Site	Kouvola		Finland	45200
14	Pfizer Investigational Site	Oulu		Finland	90100
15	Pfizer Investigational Site	Tampere		Finland	33100
16	Pfizer Investigational Site	Turku		Finland	20100
17	Pfizer Investigational Site	Garches		France	92380
18	Pfizer Investigational Site	Lyon Cedex 03		France	69437
19	Pfizer Investigational Site	Montpellier		France	34090
20	Pfizer Investigational Site	Paris		France	75020
21	Pfizer Investigational Site	Rennes Cedex 9		France	35033
22	Pfizer Investigational Site	Frankfurt		Germany	65929
23	Pfizer Investigational Site	Marburg		Germany	35039
24	Pfizer Investigational Site	Muelheim a.d. Ruhr		Germany	45468
25	Pfizer Investigational Site	Muenchen		Germany	81925
26	Pfizer Investigational Site	Rosenheim		Germany	83022
27	Pfizer Investigational Site	Holargos	Athens	Greece	15562
28	Pfizer Investigational Site	Epirus	Ioannina	Greece	45500
29	Pfizer Investigational Site	Rio	Patras	Greece	26500
30	Pfizer Investigational Site	Cefalu'	Palermo	Italy	90015
31	Pfizer Investigational Site	Firenze		Italy	50139
32	Pfizer Investigational Site	Latina		Italy	04100
33	Pfizer Investigational Site	Riga		Latvia	LV 1010
34	Pfizer Investigational Site	Moelv		Norway	N-2390
35	Pfizer Investigational Site	Oslo		Norway	NO-0257
36	Pfizer Investigational Site	Myslowice		Poland	41-400
37	Pfizer Investigational Site	Poznan		Poland	61-485
38	Pfizer Investigational Site	Szczecin		Poland	70-111
39	Pfizer Investigational Site	Szczecin		Poland	70-451
40	Pfizer Investigational Site	Szczecin		Poland	70-467
41	Pfizer Investigational Site	Wroclaw		Poland	53-020
42	Pfizer Investigational Site	Bratislava 37		Slovakia	833 31
43	Pfizer Investigational Site	Kosice		Slovakia	040 11
44	Pfizer Investigational Site	Martin		Slovakia	036 59
45	Pfizer Investigational Site	Trencin		Slovakia	911 01
46	Pfizer Investigational Site	Sabadell	Barcelona	Spain	08208
47	Pfizer Investigational Site	Manacor	Palma de Mallorca	Spain	07500
48	Pfizer Investigational Site	Aarau		Switzerland	5001
49	Pfizer Investigational Site	Zurich		Switzerland	8091
50	Pfizer Investigational Site	High Heaton	Newcastle upon Tyne	United Kingdom	NE7 7DN
51	Pfizer Investigational Site	Taunton	Somerset	United Kingdom	TA1 5DA
52	Pfizer Investigational Site	Leeds		United Kingdom	LS9 7TF

Sponsors and Collaborators

• Pfizer

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.

• ClinicalTrials.gov Identifier: NCT00479505
• Other Study ID Numbers: A3711047
• First Posted: May 28, 2007
• Last Update Posted: Mar 23, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Urinary Bladder, Overactive

Study Results

No Results Posted as of Mar 23, 2011