Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Neptune
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
2 other identifiers
interventional
1,334
12 countries
105
Brief Summary
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2010
Shorter than P25 for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedStudy Start
First participant enrolled
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
December 17, 2015
CompletedDecember 3, 2024
November 1, 2024
1.1 years
November 19, 2009
October 14, 2015
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment in Total International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Baseline and Week 12
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: - 0. No urgency; - 1. Mild urgency; - 2. Moderate urgency; - 3. Severe urgency; - 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
Baseline and Week 12
Secondary Outcomes (42)
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
Baseline and Week 12
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Baseline and Week 12
- +37 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
TOCAS 0.4 mg
ACTIVE COMPARATORParticipants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
FDC 0.4 mg/6 mg
EXPERIMENTALParticipants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
FDC 0.4 mg/9 mg
EXPERIMENTALParticipants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Interventions
tablet
tablet
tablet
tablet
tablet
Eligibility Criteria
You may qualify if:
- Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
- A total International Prostate Symptom Score (IPSS) of ≥13
- A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
- A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)
You may not qualify if:
- Any significant Post Void Residual volume (\>150 mL)
- A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
- Evidence of a symptomatic urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
Unknown Facility
Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Minsk, 220036, Belarus
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Minsk, 220114, Belarus
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Minsk, 220119, Belarus
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Antwerp, 2020, Belgium
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Antwerp, 2030, Belgium
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Assebroek, 8310, Belgium
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Sint-Truiden, 3800, Belgium
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Turnhout, 2300, Belgium
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Hradec Králové, 500 02, Czechia
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Ostrava, 700 30, Czechia
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Pilsen, 301 24, Czechia
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Prague, 180 81, Czechia
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Roudnice nad Labem, 413 01, Czechia
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Uherské Hradiště, 686 08, Czechia
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Ústí nad Labem, 40001, Czechia
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Zdar, 591 01, Czechia
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Aix-en-Provence, 13616, France
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Angers, 49033, France
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Bordeaux, 33076, France
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Colmar, 68024, France
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Dijon, 21000, France
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Dijon, 21079, France
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Lyon, 69437, France
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Montluçon, 03100, France
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Orléans, 45067, France
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Paris, 75010, France
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Paris, 75020, France
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Paris, 75679, France
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Pierre-Bénite, 69495, France
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Rennes, 35033, France
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Tours, 37044, France
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Bad Ems, 56130, Germany
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Bautzen, 02625, Germany
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Eisleben Lutherstadt, 06295, Germany
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Frankfurt, 65933, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Hamburg, 20253, Germany
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Henningsdorf, 16761, Germany
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Hettstedt, 06333, Germany
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Koblenz, 56068, Germany
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Leipzig, 04105, Germany
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Leipzig, 04109, Germany
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Neustadt in Sachsen, 01844, Germany
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Uetersen, 25436, Germany
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Budapest, 1204, Hungary
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Körmend, 9900, Hungary
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Nyíregyháza, 4400, Hungary
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Sopron, 9400, Hungary
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Szekszárd, 7100, Hungary
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Szentes, 6601, Hungary
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Tatabánya, 2800, Hungary
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Avellino, 83100, Italy
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Catania, 95124, Italy
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Catanzaro, 88100, Italy
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Florence, 50139, Italy
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Palermo, 90146, Italy
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Treviglio, 24047, Italy
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Turin, 10154, Italy
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Amsterdam, 1100 AD, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Etten-Leur, 4872 LA, Netherlands
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Maastricht, 6229 HX, Netherlands
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Sneek, 8600 BA, Netherlands
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Sneek, 8601 ZK, Netherlands
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Tilburg, 5022 GC, Netherlands
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Winterswijk, 7101 BN, Netherlands
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Bielsko-Biala, 43-300, Poland
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Bydgoszcz, 85-094, Poland
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Krakow, 31-530, Poland
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Puławy, 24-100, Poland
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Warsaw, 02-005, Poland
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Więcbork, 89-410, Poland
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Moscow, 111020, Russia
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Moscow, 111123, Russia
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Moscow, 119435, Russia
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Moscow, 125206, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 198013, Russia
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Nitra, 949 01, Slovakia
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Piešťany, 921 01, Slovakia
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Prešov, 080 01, Slovakia
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Skalica, 909 82, Slovakia
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Trenčín, 911 01, Slovakia
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Žilina, Slovakia
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Birmingham, B15 2SQ, United Kingdom
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Bristol, BS10 5NB, United Kingdom
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Bristol, BS2 8HW, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Glasgow, G20 0XA, United Kingdom
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Glasgow, G81 2DR, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Reading, RG2 0TG, United Kingdom
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Reading, RG2 7AG, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
Related Publications (1)
van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.
PMID: 23932438BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director, Global Medical Science
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 23, 2009
Study Start
January 11, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 3, 2024
Results First Posted
December 17, 2015
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.