Study summary

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.

Additional Study Details

Phase
3
Product
  • Solifenacin Succinate Suspension
  • Placebo
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    189
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A study to investigate how effective and safe Solifenacin Succinate Suspension is in treating children/adolescents aged 5 to less than 18 years with symptoms of overactive bladder (OAB) compared to a non-active drug? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
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    • Lebanon
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    • United States
    • Vietnam

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      Locations

      Contact Us
      Contact Us
      Withdrawn
      Site: 1011
      Providence, Rhode Island, United States, 02906
      Completed
      Site: 3854
      Kharkiv, Ukraine
      Completed
      Site: 5205
      Mexico City, Mexico, C.P.06700
      Withdrawn
      Site: 9103
      Lucknow, India, 226003
      Withdrawn
      Site: 5504
      Campinas, Brazil, 13083-887
      Withdrawn
      Site: 3851
      Kyiv, Ukraine, 58001
      Completed
      Site: 3812
      Novi Sad, Former Serbia and Montenegro, 21000
      Withdrawn
      Site: 4604
      Stockholm, Sweden, 17176
      Completed
      Site: 4403
      Leeds, United Kingdom, LS1 3EX
      Completed
      Site: 5507
      Campinas, Brazil, 13087-567
      Completed
      Site: 4605
      Umea, Sweden, 90185
      Withdrawn
      Site: 3206
      Esneux, Belgium, 4130
      Withdrawn
      Site: 3102
      Utrecht, Netherlands, 3584 EA
      Withdrawn
      Site: 4806
      Poznan, Poland, 61-664
      Completed
      Site: 3209
      Antwerp, Belgium, 2650
      Completed
      Site: 8201
      Seoul, Republic of Korea, 120752
      Completed
      Site: 6301
      Quezon City, Philippines, 1108
      Completed
      Site: 3204
      Kortrijk, Belgium, 8500
      Withdrawn
      Site: 9102
      Nagpur, India, 440012
      Withdrawn
      Site: 8204
      Gwangju, Republic of Korea, 501757
      Withdrawn
      Site: 5501
      Santo Andre, Brazil, 090060-650
      Completed
      Site: 1006
      Shreveport, Louisiana, United States, 71106
      Completed
      Site: 4803
      Gdansk, Poland, 80-952
      Completed
      Site: 5506
      Curitiba, Brazil, 80240-060
      Withdrawn
      Site: 3103
      Rotterdam, Netherlands, 3015 CE
      Withdrawn
      Site: 5503
      Porto Alegre, Brazil, 90035-003
      Completed
      Site: 4401
      Sheffield, United Kingdom, S10 2TH
      Completed
      Site: 1005
      Hamilton, Canada, L8N 3Z5
      Completed
      Site:8202
      Seoul, Republic of Korea, 156707
      Withdrawn
      Site: 4907
      Gottingen, Germany, 37075
      Completed
      Site: 3205
      Leuven, Belgium, 3000
      Completed
      Site: 4606
      Gothenburg, Sweden, 41685
      Completed
      Site: 1001
      Quebec, Canada, G1V 4G2
      Withdrawn
      Site: 4905
      Mainz, Germany, 55101
      Withdrawn
      Site: 4404
      London, United Kingdom, NW1 2BU
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      Site: 3903
      Torino, Italy, 10126
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      Tarrytown, New York, United States, 10591
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      Lille, France, 59037
      Withdrawn
      Site: 1013
      Saint Louis, MO, United States, 63110
      Withdrawn
      Site: 3207
      Brussels, Belgium, 1020
      Completed
      Site: 3208
      Charleroi, Belgium, 6000
      Withdrawn
      Site: 2701
      Johannesburg, South Africa, 1709
      Completed
      Site:8203
      Daegu, Republic of Korea, 705717
      Completed
      Site: 4801
      Warsaw, Poland, 04-736
      Withdrawn
      Site: 9114
      Jaipur, India, 302004
      Completed
      Site: 9001
      Ankara, Turkey, 6100
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      New Delhi, India, 110001
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      Site: 7002
      Moscow, Russian Federation, 123317
      Withdrawn
      Site: 3210
      Leuven, Belgium, 3000
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      Site: 8206
      Incheon, Republic of Korea, 400-711
      Withdrawn
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      Sao Jose do Rio Preto, Brazil, 15090-000
      Withdrawn
      Site: 1009
      Durham, North Carolina, United States, 27710
      Completed
      Site: 4804
      Lubin, Poland, 20-093
      Withdrawn
      Site: 5502
      Sao Paulo, Brazil, 05403-000
      Completed
      Site: 3853
      Dnipropetrovsk, Ukraine, 49100
      Completed
      Site: 3810
      Belgrade, Former Serbia and Montenegro, 11 000
      Withdrawn
      Site: 3104
      Zwolle, Netherlands, 8011 JW
      Withdrawn
      Site: 4906
      Frankfurt, Germany, 60435
      Completed
      Site: 9002
      Izmir, Turkey, 35100
      Withdrawn
      Site: 1007
      Stanford, California, United States, 94305
      Withdrawn
      Site: 1002
      Montreal, Canada, H3H 1P3
      Withdrawn
      Site: 3852
      Donetsk, Ukraine, 83045
      Completed
      Site: 4504
      Koge, Denmark, 4600
      Completed
      Site: 4503
      Aalborg, Denmark, DK-9000
      Terminated
      Site: 4601
      Jonkoping, Sweden, 55185
      Withdrawn
      Site: 4802
      Wroclaw, Poland, 50-369
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      Site: 9004
      Kocaeli, Turkey, 41380
      Withdrawn
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      Saint Petersburg, Russian Federation, 194100
      Withdrawn
      Site: 1004
      Toronto, Canada, M5G 1X8
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      Site: 4602
      Stockholm, Sweden, 11883
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      Saint Petersburg, Russian Federation, 194100
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      Gdansk, Poland, 80-803
      Withdrawn
      Site: 4904
      Munich, Germany, 80337
      Completed
      Site: 3201
      Gent, Belgium, 9000
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      Site: 4502
      Kolding, Denmark, 6000
      Withdrawn
      Site: 4902
      Emmendingen, Germany, 79312
      Withdrawn
      Site: 7004
      Moscow, Russian Federation, 119991
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      Site: 4501
      Aarhus N, Denmark, 8200
      Completed
      Site: 2703
      Cape Town, South Africa, 7700
      Withdrawn
      Site: 5203
      Leon, Mexico, 37000
      Withdrawn
      Site: 3811
      Belgrade, Former Serbia and Montenegro, 11 000
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      Site: 4702
      Trondheim, Norway, 7030
      Withdrawn
      Site: 9104
      Dehradun, India, 248140
      Withdrawn
      Site: 4901
      Marburg, Germany, 35043
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      Site: 9110
      Bangalore, India, 560017
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      Site: 9108
      Ahmedabad, India, 380007
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      Site: 9105
      Hyderabad, India, 500018
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      Site: 4903
      Bonn, Germany, 53105
      Withdrawn
      Site: 3902
      Firenze, Italy, 50134
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      Site: 5202
      Mexico City, Mexico, 4530
      Completed
      Site: 4701
      Bergen, Norway, 5021
      Completed
      Site: 1015
      Albany, NY, United States, 12208
      Completed
      Site: 3202
      Antwerp, Belgium, 2020
      Withdrawn
      Site: 3101
      Nijmegen, Netherlands, 6525 GA
      Completed
      Site: 3203
      Gent, Belgium, 9000
      Withdrawn
      Site: 9005
      Istanbul, Turkey
      Withdrawn
      Site: 9003
      Ankara, Turkey, 6100
      Withdrawn
      Site: 1012
      Phoenix, Arizona, United States, 85032
      Withdrawn
      Site: 3901
      Roma, Italy, 165
      Completed
      Site: 4603
      Skovde, Sweden, 54185
      Withdrawn
      Site: 7005
      Moscow, Russian Federation
      Withdrawn
      Site: 5204
      Mexico City, Mexico, 78218
      Withdrawn
      Site: 3301
      Paris, France, 75015
      Completed
      Site: 8207
      Seoul, Republic of Korea, 110744
      Withdrawn
      Site: 1014
      Cincinnati, OH, United States, 45229
      Completed
      Site: 3850
      Kiev, Ukraine, 1103

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