Trial record 1 of 2 for:
secnidazole + trichomoniasis
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03935217 |
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Recruitment Status :
Completed
First Posted : May 2, 2019
Last Update Posted : October 1, 2021
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Sponsor:
Lupin Research Inc
Information provided by (Responsible Party):
Lupin Research Inc
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Trichomonas Infection | Drug: Secnidazole Drug: Placebo | Phase 3 |
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). After all Visit 2 study procedures have been completed, 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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 147 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 23, 2019 |
| Actual Primary Completion Date : | March 18, 2020 |
| Actual Study Completion Date : | March 18, 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Secnidazole
| Arm | Intervention/treatment |
|---|---|
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Experimental: Solosec (containing 2 grams of secnidazole)
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (placebo)
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Drug: Secnidazole
Oral Granules containing secnidazole
Other Name: Solosec® Drug: Placebo Oral Granules of placebo manufactured to mimic secnidazole |
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Placebo Comparator: Placebo
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (Solosec (containing 2 grams of secnidazole)
|
Drug: Secnidazole
Oral Granules containing secnidazole
Other Name: Solosec® Drug: Placebo Oral Granules of placebo manufactured to mimic secnidazole |
Primary Outcome Measures :
- Microbiological Cure [ Time Frame: Study Day 6-12 ]Vaginal Culture negative for T. vaginalis at TOC Visit
Other Outcome Measures:
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Must be female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult female or post-menarche adolescent girl ≥12 years of age in general good health
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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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935217
Locations
| United States, Alabama | |
| Site 1007 | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| Site 1003 | |
| North Miami, Florida, United States, 33161 | |
| United States, Illinois | |
| Site 1014 | |
| Chicago, Illinois, United States, 60605 | |
| United States, Mississippi | |
| Site 1013 | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Jersey | |
| Site 1009 | |
| Lawrenceville, New Jersey, United States, 08648 | |
| United States, North Carolina | |
| Site 1008 | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Site 1004 | |
| Fayetteville, North Carolina, United States, 28304 | |
| United States, South Carolina | |
| Site 1011 | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Site 1001 | |
| Memphis, Tennessee, United States, 38104 | |
| Site 1002 | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Virginia | |
| Site 1006 | |
| Virginia Beach, Virginia, United States, 23456 | |
Sponsors and Collaborators
Lupin Research Inc
Investigators
| Study Director: | Jackie Shaw | Director, Clinical Operations |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lupin Research Inc |
| ClinicalTrials.gov Identifier: | NCT03935217 |
| Other Study ID Numbers: |
SEC-WH-301 |
| First Posted: | May 2, 2019 Key Record Dates |
| Last Update Posted: | October 1, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lupin Research Inc:
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Vaginal Itching Vaginal Discharge |
Additional relevant MeSH terms:
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Trichomonas Infections Protozoan Infections Parasitic Diseases Infections |
Secnidazole Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |