Perry, Caroline R. http://orcid.org/0000-0001-6387-319X
Scangarella-Oman, Nicole E. http://orcid.org/0000-0003-4211-8261
Millns, Helen
Flight, William http://orcid.org/0000-0003-3343-4211
Gatsi, Sally http://orcid.org/0000-0002-4825-9578
Jakielaszek, Charles http://orcid.org/0000-0003-4839-0266
Janmohamed, Salim
Lewis, David A. http://orcid.org/0000-0002-5534-8392
Clinical trials referenced in this document:
Documents that mention this clinical trial
Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea
https://doi.org/10.1136/sextrans-2022-055518
Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study
https://doi.org/10.1007/s40121-023-00862-6
Funding for this research was provided by:
GSK
Article History
Received: 21 June 2023
Accepted: 18 August 2023
First Online: 26 September 2023
Declarations
:
: Caroline R. Perry, Nicole E. Scangarella-Oman, Helen Millns, William Flight, Sally Gatsi, Charles Jakielaszek, and Salim Janmohamed are employees of, and shareholders in, GSK. David A. Lewis is employed by Western Sydney Local Health District and has no disclosures to declare.
: These studies are conducted in accordance with the protocols and consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, International Council on Harmonization Good Clinical Practice Guidelines, and applicable laws and regulations. Protocol and amendments, informed consent form/adolescent assent form/eConsent (if applicable), investigator’s brochure, and other relevant documents (e.g., advertisements) were submitted to an institutional review board/independent ethics committee (IRB/IEC) by the investigator and reviewed and approved by the IRB/IEC before the study was initiated. The master IRB was Advarra Institutional Review Board (Columbia, MD, USA), while study sites outside the USA used their appropriate local IRB/IEC. Adolescent patients will only be enrolled at study sites where investigators have experience in this population and if allowed per the study site’s institutional ethics committees and local country/national regulatory guidelines; enrollment will be contingent upon such approvals.