A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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). 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Drug: Secnidazole
Oral Granules containing secnidazole
Other Names:
Drug: Placebo
Oral Granules of placebo manufactured to mimic secnidazole
|
| 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 Names:
Drug: Placebo
Oral Granules of placebo manufactured to mimic secnidazole
|
Outcome Measures
Primary Outcome Measures
- Microbiological Cure [Study Day 6-12]
Vaginal Culture negative for T. vaginalis at TOC Visit
Other Outcome Measures
- Outcome Responders [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
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 1007 | Birmingham | Alabama | United States | 35294 |
| 2 | Site 1003 | North Miami | Florida | United States | 33161 |
| 3 | Site 1014 | Chicago | Illinois | United States | 60605 |
| 4 | Site 1013 | Jackson | Mississippi | United States | 39216 |
| 5 | Site 1009 | Lawrenceville | New Jersey | United States | 08648 |
| 6 | Site 1008 | Chapel Hill | North Carolina | United States | 27599 |
| 7 | Site 1004 | Fayetteville | North Carolina | United States | 28304 |
| 8 | Site 1011 | Charleston | South Carolina | United States | 29425 |
| 9 | Site 1001 | Memphis | Tennessee | United States | 38104 |
| 10 | Site 1002 | Memphis | Tennessee | United States | 38120 |
| 11 | Site 1006 | Virginia Beach | Virginia | United States | 23456 |
Sponsors and Collaborators
- Lupin Research Inc
Investigators
- Study Director: Jackie Shaw, Director, Clinical Operations
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEC-WH-301