STAR: Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00802373

Collaborator

(none)

1,355

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Drug: Solifenacin succinate Drug: Tolterodine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1355 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Solifenacin succinate 5/10mg	Drug: Solifenacin succinate oral Other Names: YM905 Vesicare
Experimental: II Tolterodine 4mg	Drug: Tolterodine Oral

Arm

Intervention/Treatment

Experimental: I

Solifenacin succinate 5/10mg

Drug: Solifenacin succinate

oral

Other Names:

YM905

Vesicare

Experimental: II

Tolterodine 4mg

Drug: Tolterodine

Oral

Outcome Measures

Primary Outcome Measures

Change from baseline in mean number of micturitions per 24 hours [Weeks 4, 8 and 12]

Secondary Outcome Measures

Change from baseline in mean urgency frequency per 24 hours [Weeks 4, 8 and 12]
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours [Weeks 4, 8 and 12]
Change from baseline in mean volume voided per micturition [Weeks 4, 8 and 12]
Change from baseline in number of pads used [Weeks 4, 8 and 12]
Change from baseline in mean nocturia episodes per 24 hours [Weeks 4, 8 and 12]
Percentage of patients requiring an increase in the dose of the study medication [Weeks 4, 8 and 12]
Change from baseline in patient perception of bladder condition [Weeks 4, 8 and 12]
Patient assessment of treatment benefit [Weeks 4, 8 and 12]
Physician assessment of treatment benefit [Weeks 4, 8 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At study entry:

Patient is willing and able to complete the micturition diary correctly
Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for >= 3 months

At randomization:

Patient must experience frequency of micturition on average >= 8 times per 24 hour period during the 3 day micturition diary period
Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
At least 3 episodes of urinary incontinence or,
Patients must exhibit urgency at least 3 times

Exclusion Criteria:

At study entry:

Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
Clinically significant outflow obstruction (at the discretion of the investigator)
Significant post void residual volume (PVR>200ml)
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
Patient with a neurological cause for abnormal detrusor activity
Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
Non drug treatment including electrostimulation therapy or start of a bladder training program during the 2 weeks prior to entry into, or during the study
Use of drugs intended to treat urinary incontinence
Diabetic neuropathy
Known or suspected hypersensitivity to solifenacin, tolterodine, other anticholinergics or lactose
Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
Participation in any clinical trial within 30 (90 in the UK) days prior to randomisation
Employees of the Yamanouchi Group, third parties associated with the study, or the study site

At randomization:

Patient who did not complete the micturition diary according to the instructions
Total daily urine volume > 3000 ml as verified in the micturition diary

Contacts and Locations

Locations

	City	Country
1	Minsk	Belarus
2	Antwerp	Belgium
3	Brussels	Belgium
4	Gent	Belgium
5	Middleheim	Belgium
6	Brno	Czech Republic
7	Budejovice	Czech Republic
8	Bulovce	Czech Republic
9	Melnik	Czech Republic
10	Prague	Czech Republic
11	Aalborg	Denmark
12	Aarhus	Denmark
13	Copenhagen	Denmark
14	Glostrup	Denmark
15	Herlev	Denmark
16	Kolding	Denmark
17	Odense	Denmark
18	Angers	France
19	Bordeaux	France
20	Clermont-Ferrand	France
21	Lille	France
22	Nantes	France
23	Paris	France
24	Reims	France
25	Rouen	France
26	Saint Priest en Jarez	France
27	Toulouse	France
28	Bad Ems	Germany
29	Emmendingen	Germany
30	Frankfurt	Germany
31	Freiburg	Germany
32	Hagenow	Germany
33	Hamburg	Germany
34	Koblenz	Germany
35	Rheinfelden	Germany
36	Trier	Germany
37	Uetersen	Germany
38	Athens	Greece
39	Larisa	Greece
40	Patras	Greece
41	Thessaloniki	Greece
42	Budapest	Hungary
43	Nyiregyhaza	Hungary
44	Szolnok	Hungary
45	Tatabanya	Hungary
46	Montecchio Emilia	Italy
47	Novara	Italy
48	Orbassano	Italy
49	Rome	Italy
50	Sassari	Italy
51	Sesto San Giovanni	Italy
52	Varese	Italy
53	Verona	Italy
54	Apeldoorn	Netherlands
55	Ede	Netherlands
56	Eindhoven	Netherlands
57	Groningen	Netherlands
58	Nijmegen	Netherlands
59	Roermond	Netherlands
60	Tilburg	Netherlands
61	Zeist	Netherlands
62	Bodo	Norway
63	Haugesund	Norway
64	Rud	Norway
65	Tonsberg	Norway
66	Moscow	Russian Federation
67	St. Petersburg	Russian Federation
68	Bratislava	Slovakia
69	Kosice	Slovakia
70	Martin	Slovakia
71	Presov	Slovakia
72	Skalica	Slovakia
73	Alicante	Spain
74	Bilbao	Spain
75	Burgos	Spain
76	Llobregat	Spain
77	Madrid	Spain
78	Santiago de Compostela	Spain
79	Sevilla	Spain
80	Valencia	Spain
81	Valladolid	Spain
82	Gothenburg	Sweden
83	Malmo	Sweden
84	Nykoping	Sweden
85	Stockholm	Sweden
86	Kiev	Ukraine
87	Birmingham	United Kingdom
88	Harrow	United Kingdom
89	Leicester	United Kingdom
90	Liverpool	United Kingdom
91	London	United Kingdom
92	Plymouth	United Kingdom
93	Sheffield	United Kingdom
94	Stevenage	United Kingdom
95	Swansea	United Kingdom