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Urinary Bladder, OveractivePhase 3SUNRISENCT00801944

Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms

A Phase 3 study testing Solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 78 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
Solifenacin succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
973 participants
Where
78 sitesin 14 countries
Study dates
Apr 2004to Oct 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is willing and able to complete the micturition diary correctly.
  • Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for >= 3 months
  • At least 3 episodes of urgency with or without incontinence in last 3 days
  • At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
  • Patient must experience frequency of micturition on average >= 8 times per 24-hour period during the 3-day micturition diary period

Who cannot join

  • 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 or patch 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 indwelling catheters or practising intermittent self-catheterisation
  • 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
Show all 14Show fewer
  • Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
  • Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
  • Use of drugs intended to treat urinary incontinence
  • Diabetic neuropathy
  • 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 days prior to randomisation
  • Employees of the Yamanouchi Group, third parties associated with the study, or the study site
  • Patient who did not complete the micturition diary according to the instructions

Trial locations and contacts

78 sites in 14 countries.

78 sites in 14 countries

Germany14 sites

  • Study site

    Aichach

  • Study site

    Bad Neuenaher

  • Study site

    Bamberg

  • Study site

    Bautzen

  • Study site

    Berlin

  • Study site

    Dierdorf

  • Study site

    Dülmen

  • Study site

    Düsseldorf

  • Study site

    Frankfurt

  • Study site

    Henningsdorf

  • Study site

    Munich

  • Study site

    Neustadt

  • Study site

    Nuremberg

  • Study site

    Planegg

Other trials in Germany

United Kingdom13 sites

  • Study site

    Birmingham

  • Study site

    Cottingham

  • Study site

    Croydon

  • Study site

    Edinburgh

  • Study site

    Huntingdon

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Oldham

  • Study site

    Stoke-on-Trent

  • Study site

    Sunderland

  • Study site

    Torbay

  • Study site

    Welwyn Garden City

  • Study site

    Worthing

Other trials in United Kingdom

Belgium8 sites

  • Study site

    Antwerp

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Hasselt

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Italy8 sites

  • Study site

    Bari

  • Study site

    Catanzaro

  • Study site

    Cinisello Balsamo

  • Study site

    Magenta

  • Study site

    Modena

  • Study site

    Perugia

  • Study site

    Turin

  • Study site

    Udine

Other trials in Italy

Spain7 sites

  • Study site

    Barcelona

  • Study site

    Coaña

  • Study site

    Córdoba

  • Study site

    Madrid

  • Study site

    Mérida

  • Study site

    San Cristóbal de La Laguna

  • Study site

    Seville

Other trials in Spain

France6 sites

  • Study site

    Lille

  • Study site

    Lomme

  • Study site

    Mulhouse

  • Study site

    Nantes

  • Study site

    Nîmes

  • Study site

    Paris

Other trials in France

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Nyíregyháza

  • Study site

    Pécs

  • Study site

    Szeged

  • Study site

    Tatabánya

Other trials in Hungary

Portugal4 sites

  • Study site

    Abrantes

  • Study site

    Lisbon

  • Study site

    Porto

  • Study site

    Santarém

Other trials in Portugal

Czechia3 sites

  • Study site

    Ostrava

  • Study site

    Prague

  • Study site

    Zlín

Other trials in Czechia

Greece3 sites

  • Study site

    Athens

  • Study site

    Crete

  • Study site

    Ioannina

Other trials in Greece

Slovakia3 sites

  • Study site

    Banska Bysterica

  • Study site

    Martin

  • Study site

    Žilina

Other trials in Slovakia

Poland2 sites

  • Study site

    Bydgoszcz

  • Study site

    Wroclaw

Other trials in Poland

Egypt1 site

  • Study site

    Al Mansurah

Other trials in Egypt

Russia1 site

  • Study site

    Moscow

Other trials in Russia

About this study

Official title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

Being tested
Solifenacin succinate, Placebo
Keywords
Overactive Bladder
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solifenacin succinateDrug

    Also called YM905, Vesicare

    oral

  • PlaceboDrug

    oral

Study groups in NCT00801944
Study groupRoleWhat they receive
IExperimentalSolifenacin succinate 5/10mg
Receives: Drug: Solifenacin succinate
IIExperimentalPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4

    Measured: Week 16

Secondary outcomes (6)

  1. Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)

    Measured: Week 16

  2. Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours

    Measured: Week 16

  3. Change from baseline in patient perception of bladder condition (PBC)

    Measured: Week 16

  4. Change from baseline in patient perception of urgency 'bother' (UB-VAS)

    Measured: Week 16

  5. Percentage of patients requiring an increase in the dose of the study medication

    Measured: Week 8

  6. Patient assessment of treatment satisfaction (TS-VAS)

    Measured: Weeks 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2008 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
973 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801944
Sponsor's protocol ID
905-EC-002
Acronym
SUNRISE
Status last verified
Sep 2014
First submitted
2 Dec 2008
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.

    PubMed 18990175

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PubMed 37160401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 78 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Germany, United Kingdom, Belgium, Italy, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801944, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.

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