Last updated: 02/01/2021 23:20:05

BOTOX Drug Use Investigation (Strabismus)

GSK study ID
201600
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: BOTOX Drug Use Investigation (Strabismus)
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in subjects with strabismus who are treated with botulinum toxin type A for the first time. BOTOX is a registered trademark. The brands listed are trademarks of their respective owners and, unless otherwise stated, are not trademarks of GSK.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 1 year at longest

Secondary outcomes:
Not applicable
Interventions:
  • Drug: botulinum toxin type A
    • Enrollment:
    300
    Primary completion date:
    2019-27-02
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Masahiko Hamochi, Yoshiyuki Yamashita,Keiko Tabata,Takuma Danjo,Shinya Nachi, Terufumi Hara. Safety and effectiveness of botulinum toxin type A (BOTOX) in the treatment for strabismus - Report of drug use investigation (DUI). Prog Med. 2020;40(10):1093-1102
    Medical condition
    Strabismus
    Product
    OnabotulinumtoxinA
    Collaborators
    Not applicable
    Study date(s)
    September 2015 to February 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    None
    • Subjects with strabisumus
    • Subjects who are treated with botulinum toxin type A for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with strabisumus
    • Subjects who are treated with botulinum toxin type A for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2019-27-02
    Actual study completion date
    2019-27-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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