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

• ClinicalTrials.gov Identifier: NCT03935217
• Recruitment Status: Completed
• First Posted: May 2, 2019
• Last Update Posted: April 21, 2020
• Sponsor: Lupin Research Inc
• Information provided by (Responsible Party): Lupin Research Inc

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
Trichomonas Infection	Drug: Secnidazole; Drug: Placebo	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

• 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: 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® Granules Containing 2 Grams of Secnidazole 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

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 Name: Solosec®; 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 Name: Solosec®; Drug: Placebo; Oral Granules of placebo manufactured to mimic secnidazole

Outcome Measures

Primary Outcome Measures :

1. Microbiological Cure [ Time Frame: Study Day 6-12 ]
   Vaginal Culture negative for T. vaginalis at TOC Visit

Other Outcome Measures:

1. 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

Eligibility Criteria

• 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

• 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

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

More Information

• Responsible Party: Lupin Research Inc
• ClinicalTrials.gov Identifier: NCT03935217
• Other Study ID Numbers: SEC-WH-301
• First Posted: May 2, 2019
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lupin Research Inc:

Vaginal Itching; Vaginal Discharge

Additional relevant MeSH terms:

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Secnidazole; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents