A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis

Trichomonas Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935217
• Other study ID #: SEC-WH-301
• Status: Completed
• Phase: Phase 3
• 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
• 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 OSOM® 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).

Related Conditions & MeSH terms

• Trichomonas Infection
• Trichomonas Infections

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