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

October 2, 2023 updated by: Lupin Research Inc

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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)]

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Site 1007
    • Florida
      • North Miami, Florida, United States, 33161
        • Site 1003
    • Illinois
      • Chicago, Illinois, United States, 60605
        • Site 1014
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Site 1013
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Site 1009
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Site 1008
      • Fayetteville, North Carolina, United States, 28304
        • Site 1004
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site 1011
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Site 1001
      • Memphis, Tennessee, United States, 38120
        • Site 1002
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Site 1006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solosec (containing 2 grams of secnidazole)
Orally administered as a single dose with applesauce.
Oral Granules containing secnidazole
Other Names:
  • Solosec®
Placebo Comparator: Placebo
Orally administered as a single dose with applesauce.
Oral Granules of placebo manufactured to mimic secnidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological Cure at the TOC Visit
Time Frame: Study Day 6-12
Vaginal Culture negative for T. vaginalis at TOC Visit
Study Day 6-12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Responders
Time Frame: Study Day 6-12
Complete resolution of trichomoniasis symptoms (i.e. itching, discharge and odor recorded as normal) and vaginal culture result negative for T. vaginalis at TOC Visit
Study Day 6-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jackie Shaw, Director, Clinical Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Actual)

March 2, 2020

Study Completion (Actual)

March 25, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

After publication of the primary study results, the research team will prepare final research data files that may be shared with other investigators, upon request.

IPD Sharing Access Criteria

Requests for research data must be submitted to author CAM in writing, via a standard data request form, with a justification for how the data will be used. Author CAM and Lupin Pharmaceuticals will review all requests for research data obtained from this study. The mechanism by which the data will be made available to investigators will follow all NIH guidelines for data sharing as they evolve. At a minimum this would consist of a data use agreement that provides for commitments to use the data for research purposes only, secure the data with appropriate computer technology, obtain IRB approval, and destroy (or return) the data after analyses are complete.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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