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

NCT ID: NCT03935217

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2020-03-25

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 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)]

Conditions

Trichomonas Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Solosec (containing 2 grams of secnidazole)

Orally administered as a single dose with applesauce.

Group Type: EXPERIMENTAL

Secnidazole

Intervention Type: DRUG

Oral Granules containing secnidazole

Placebo

Orally administered as a single dose with applesauce.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Granules of placebo manufactured to mimic secnidazole

Interventions

Secnidazole

Oral Granules containing secnidazole

Intervention Type: DRUG

Placebo

Oral Granules of placebo manufactured to mimic secnidazole

Intervention Type: DRUG

Other Intervention Names

Solosec®

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lupin Research Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jackie Shaw

Role: STUDY_DIRECTOR

Director, Clinical Operations

Locations

Site 1007

Birmingham, Alabama, United States

Site 1003

North Miami, Florida, United States

Site 1014

Chicago, Illinois, United States

Site 1013

Jackson, Mississippi, United States

Site 1009

Lawrenceville, New Jersey, United States

Site 1008

Chapel Hill, North Carolina, United States

Site 1004

Fayetteville, North Carolina, United States

Site 1011

Charleston, South Carolina, United States

Site 1001

Memphis, Tennessee, United States

Site 1002

Memphis, Tennessee, United States

Site 1006

Virginia Beach, Virginia, United States

Countries

United States

References

Muzny CA, Van Gerwen OT, Kaufman G, Chavoustie S. Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data. BMJ Open. 2023 Aug 7;13(8):e072071. doi: 10.1136/bmjopen-2023-072071.

Reference Type: DERIVED

PMID: 37550019 (View on PubMed)

Muzny CA, Schwebke JR, Nyirjesy P, Kaufman G, Mena LA, Lazenby GB, Van Gerwen OT, Graves KJ, Arbuckle J, Carter BA, McMahon CP, Eder S, Shaw J, Pandey B, Chavoustie SE. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis. 2021 Sep 15;73(6):e1282-e1289. doi: 10.1093/cid/ciab242.

Reference Type: DERIVED

PMID: 33768237 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SEC-WH-301

Identifier Type: -

Identifier Source: org_study_id