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

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ClinicalTrials.gov Identifier: NCT03935217
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lupin Research Inc

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Secnidazole

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




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



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
  • 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


Contacts
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Contact: Jackie Shaw, BS 443-853-7025 jackieshaw@lupin.com
Contact: Nikki Adetoro, MPH 443-447-4534 nikkiadetoro@lupin.com

Locations
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United States, Alabama
Site 1007 Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Site 1010 Recruiting
Tucson, Arizona, United States, 85712
United States, Florida
Site 1005 Recruiting
Leesburg, Florida, United States, 34748
Site 1003 Recruiting
North Miami, Florida, United States, 33161
United States, New Jersey
Site 1009 Recruiting
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Site 1008 Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Site 1004 Recruiting
Fayetteville, North Carolina, United States, 28304
United States, South Carolina
Site 1011 Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Site 1001 Recruiting
Memphis, Tennessee, United States, 38104
Site 1002 Recruiting
Memphis, Tennessee, United States, 38120
United States, Virginia
Site 1006 Recruiting
Virginia Beach, Virginia, United States, 23456
Sponsors and Collaborators
Lupin Research Inc
Investigators
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Study Director: Jackie Shaw Director, Clinical Operations

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Responsible Party: Lupin Research Inc
ClinicalTrials.gov Identifier: NCT03935217     History of Changes
Other Study ID Numbers: SEC-WH-301
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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:
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Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Secnidazole
Metronidazole
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents