Journal article
Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
Clinical and experimental obstetrics & gynecology, v 46(4), pp 615-617
01 Jan 2019
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Purpose of Investigation: In 2016, the US Food and Drug Administration updated the enrollment and clinical response criteria for clinical studies of bacterial vaginosis (BV). The purpose of this post hoc analysis was to determine the effects of these differences on the results of a previously published phase 3 clinical study of the use of a single oral dose of secnidazole 2 grams to treat BV. Results: The updated guidelines for enrollment include a more stringent baseline Nugent score cutoff, which reduced the number of subjects from the initial study by 16.8% (secnidazole group) and 7.0% (placebo group). The updated efficacy guidelines changed the clinical outcome responder rates to 64.0% (secnidazole) and 26.4% (placebo) on assessment days 7-14 (p < 0.001), and to 58.4% and 24.5%, respectively, on days 21-30 (p < 0.001). Conclusion: Although the guidelines did not significantly affect efficacy outcomes, future BV studies will need to screen more patients to compensate for the new, more stringent enrollment criteria.
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Details
- Title
- Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
- Creators
- P. Nyirjesy - Drexel Univ, Coll Med, Dept Obstet & Gynecol, 245 North 15th St,Mailstop 495, Philadelphia, PA 19102 USAM. Padula - Virtuoso Healthcare Grp, Manhasset, NY USAJ. L. Amprey - Symbiomix Therapeut, Newark, NJ USA
- Publication Details
- Clinical and experimental obstetrics & gynecology, v 46(4), pp 615-617
- Publisher
- 7847050 CANADA INC
- Number of pages
- 3
- Grant note
- Symbiomix T Therapeutics
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000475300700023
- Scopus ID
- 2-s2.0-85072098131
- Other Identifier
- 991019350592804721
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- Web of Science research areas
- Obstetrics & Gynecology