Back to resultsA Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
Primary Purpose
Trichomonas Infection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Secnidazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Trichomonas Infection focused on measuring Vaginal Itching, Vaginal Discharge
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).
Sites / Locations
- Site 1007
- Site 1003
- Site 1014
- Site 1013
- Site 1009
- Site 1008
- Site 1004
- Site 1011
- Site 1001
- Site 1002
- Site 1006
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Solosec (containing 2 grams of secnidazole)
Placebo
Arm Description
Orally administered as a single dose with applesauce.
Orally administered as a single dose with applesauce.
Outcomes
Primary Outcome Measures
Microbiological Cure at the TOC Visit
Vaginal Culture negative for T. vaginalis at TOC Visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03935217
Brief Title
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lupin Research Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonas Infection
Keywords
Vaginal Itching, Vaginal Discharge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solosec (containing 2 grams of secnidazole)
Arm Type
Experimental
Arm Description
Orally administered as a single dose with applesauce.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered as a single dose with applesauce.
Intervention Type
Drug
Intervention Name(s)
Secnidazole
Other Intervention Name(s)
Solosec®
Intervention Description
Oral Granules containing secnidazole
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Granules of placebo manufactured to mimic secnidazole
Primary Outcome Measure Information:
Title
Microbiological Cure at the TOC Visit
Description
Vaginal Culture negative for T. vaginalis at TOC Visit
Time Frame
Study Day 6-12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must be female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackie Shaw
Organizational Affiliation
Director, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Site 1007
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Site 1003
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Site 1014
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Site 1013
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Site 1009
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Site 1008
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Site 1004
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Site 1011
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Site 1001
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Site 1002
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Site 1006
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33768237
Citation
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.
Results Reference
derived
Learn more about this trial
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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