- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935217
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Site 1007
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Florida
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North Miami, Florida, United States, 33161
- Site 1003
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Illinois
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Chicago, Illinois, United States, 60605
- Site 1014
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Mississippi
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Jackson, Mississippi, United States, 39216
- Site 1013
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Site 1009
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Site 1008
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Fayetteville, North Carolina, United States, 28304
- Site 1004
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South Carolina
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Charleston, South Carolina, United States, 29425
- Site 1011
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Tennessee
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Memphis, Tennessee, United States, 38104
- Site 1001
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Memphis, Tennessee, United States, 38120
- Site 1002
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Virginia
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Virginia Beach, Virginia, United States, 23456
- Site 1006
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Investigators
- Study Director: Jackie Shaw, Director, Clinical Operations
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEC-WH-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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