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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03935217
Other study ID # SEC-WH-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 23, 2019
Est. completion date March 25, 2020

Study information

Verified date September 2023
Source Lupin Research Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 1:1 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 investigator's 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 2/TOC (Day 6-12)]


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date March 25, 2020
Est. primary completion date March 2, 2020
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility Inclusion Criteria: - adult female or post-menarche adolescent girl =12 years of age in general good health - Have a diagnosis of trichomoniasis at the screening visit as determined by one of the following: - positive T. vaginalis NAAT test within 30 days of screening for which treatment has not been initiated. - positive OSOMĀ® rapid test. - positive wet mount assessment. - Agree to abstain from vaginal intercourse until the final study visit - Agree not to have any vaginal penetration or use of any vaginal products for the duration of the study Exclusion Criteria: - Are pregnant, lactating, or planning to become pregnant during the study. - Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak - Are suspected clinically of having an acute urinary tract infection. - Have active genital lesions, including primary syphilitic chancres and herpes simplex virus lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts may be enrolled). - Have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the Baseline Visit (Day 1).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Secnidazole
Oral Granules containing secnidazole
Placebo
Oral Granules of placebo manufactured to mimic secnidazole

Locations

Country Name City State
United States Site 1007 Birmingham Alabama
United States Site 1008 Chapel Hill North Carolina
United States Site 1011 Charleston South Carolina
United States Site 1014 Chicago Illinois
United States Site 1004 Fayetteville North Carolina
United States Site 1013 Jackson Mississippi
United States Site 1009 Lawrenceville New Jersey
United States Site 1001 Memphis Tennessee
United States Site 1002 Memphis Tennessee
United States Site 1003 North Miami Florida
United States Site 1006 Virginia Beach Virginia

Sponsors (1)

Lead Sponsor Collaborator
Lupin Research Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiological Cure at the TOC Visit Vaginal Culture negative for T. vaginalis at TOC Visit Study Day 6-12