Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03935217
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2019-04-30
Brief Title:
A Phase 3 Study of Solosec for the Treatment of Trichomoniasis
Sponsor:
Lupin Research Inc
Organization:
Lupin Research Inc
Study Overview
Official Title:
Multi-center Prospective Randomized Placebo-Controlled Delayed Treatment Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec for the Treatment of Trichomoniasis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 multi-center prospective randomized placebo-controlled delayed treatment double-blind study to evaluate the effectiveness and safety of a single oral dose of Solosec containing 2 grams of secnidazole in female patients with trichomoniasis
Detailed Description:
The study will consist of a primary study phase Visit 1 baseline to Visit 2 Day 6-12 and a follow-up phase Visit 2 to Visit 3 7-12 days post Visit 2 During the primary phase patients will be randomly assigned in a 11 ratio to either Solosec or placebo Patients will return to the clinic for the test of cure TOC visit to be conducted on Days 6-12 Visit 2
To ensure all patients receive treatment and to maintain the double-blind after completion of the primary phase patients will receive the opposite treatment placebo patients will receive Solosec and vice versa Patients with V2 cultures that are subsequently positive for T vaginalis will return to the clinic for Visit 3 V3 assessments and investigator assessment of need for additional therapy an additional Visit 4 may be scheduled at the investigators discretion if culture at V3 is positive
Summary of results includes data reported during the primary phase of the study Visit 1 baseline to Visit 2TOC Day 6-12
To ensure all patients receive treatment and to maintain the double-blind after completion of the primary phase patients will receive the opposite treatment placebo patients will receive Solosec and vice versa Patients with V2 cultures that are subsequently positive for T vaginalis will return to the clinic for Visit 3 V3 assessments and investigator assessment of need for additional therapy an additional Visit 4 may be scheduled at the investigators discretion if culture at V3 is positive
Summary of results includes data reported during the primary phase of the study Visit 1 baseline to Visit 2TOC Day 6-12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None