Last updated: 11/07/2018 07:16:13
An open label, randomized, up-titration study to assess the effect of urine sample handling procedures on the safety results of urine obtained from healthy subjects receiving repeat doses of ezogabine/retigabine.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: An open label, randomized, up-titration study to assess the effect of urine sample handling procedures on the safety results of urine obtained from healthy subjects receiving repeat doses of ezogabine/retigabine.
Trial description: An open label, randomized, up-titration study to assess the effect of urine sample handling procedures on the safety results of urine obtained from healthy subjects receiving repeat doses of ezogabine/retigabine.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Neil Brickel, Sarah DeRossett, Mauro Buraglio, Christopher Evans, Siôn Jones. An investigation of the impact of urine handling procedures on the interpretation of urinalysis findings and product safety in subjects treated with ezogabine/retigabine. Ther Clin Risk Manage. 2013;9:207-213.
Medical condition
Epilepsy
Product
retigabine
Collaborators
Not applicable
Study date(s)
April 2010 to July 2010
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
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
Not applicable
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2010-19-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website