Last updated: 02/01/2021 23:20:05
BOTOX Drug Use Investigation (Strabismus)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2019-27-02
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)
No location data available.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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