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Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

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ClinicalTrials.gov Identifier: NCT03937869
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Lupin Research Inc

Brief Summary:
A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV

Condition or disease Intervention/treatment Phase
Bacterial Vaginoses Drug: Secnidazole Phase 4

Detailed Description:
This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Study to Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g Oral Granules for the Treatment of Adolescent Girls With Bacterial Vaginosis
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
Drug Information available for: Secnidazole

Arm Intervention/treatment
Single dose Solosec (secnidazole) 2g oral
Solosec 2 grams, oral
Drug: Secnidazole
One dose
Other Name: Solosec™




Primary Outcome Measures :
  1. Clinical Outcome Responder [ Time Frame: At TOC visit study day 7-14 ]
    Defined as patients with resolution of abnormal vaginal , negative 10% KOF WHIFF test, and Clue cells less than 20% of the total epithelial cells

  2. Nugent Score [ Time Frame: At TOC visit study day 7-14 ]
    All patients with a score of 0-3 will be considered normal; scores of 4 and above will considered abnormal.

  3. Investigator Clinical Assessment [ Time Frame: At TOC visit study day 7-14 ]
    Investigator's opinion of the need for additional BV treatment. (Yes/No)

  4. Patient's Continued Clinical Response [ Time Frame: At TOC visit study day 7-14 ]
    Investigator's opinion of the continued clinical response to treatment (Yes/No)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   must be adolescent females ages 12-17 years of age
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are adolescent girls 12-17 years of age.
  2. Are willing and able to give written informed assent with a written informed consent from a parent or legal guardian.
  3. Are in good general health including as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
  4. Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
  5. Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator (e.g., oral contraception, implantable, injectable or transdermal hormonal contraception, intrauterine device [IUD], double-barrier methods, have a vasectomized partner or abstinence [if the patient becomes sexually active they must use one of the acceptable methods of birth control]). Note: NuvaRing® or any other vaginal ring products are not permitted.
  6. Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:

    1. Off-white (milky or gray), thin, homogeneous vaginal discharge AND
    2. Vaginal pH > 4.5 AND
    3. Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount AND
    4. A positive 10% KOH Whiff test.
  7. Agree to abstain from vaginal intercourse until after the TOC visit.
  8. Agree not to have any vaginal penetration or use of any vaginal products until after the TOC visit (e.g., spermicides, condoms, diaphragms, vibrators, tampons, etc.).
  9. Agree not to use vaginal douches or similar products for the duration of the study.

Exclusion Criteria:

  1. Are pregnant, lactating, or planning to become pregnant during the study.
  2. Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
  3. Are menopausal as determined by the Investigator.
  4. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex or human papilloma virus.
  5. Have active genital lesions, including active Herpes simplex 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 that are not being treated may be enrolled).
  6. Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1).
  7. Are using NuvaRing® or any other vaginal ring products.
  8. Have consumed any alcohol within 12 hours prior to treatment with study medication.
  9. Have a history of drug or alcohol abuse within the past 6 months, as determined by the Investigator.
  10. Have participated in any investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the Baseline Visit (Day 1).
  11. Are participating in any investigational, observational or non-interventional study (either currently or during the study).
  12. Have had previous exposure to SYM-1219 or participation in other clinical trials of SYM-1219.
  13. Have a known allergy to nitroimidazoles (e.g., metronidazole, tinidazole, nimorazole, etc.).
  14. Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline Visit (Day 1).
  15. Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
  16. Have any condition that interferes with their ability to understand or comply with the requirements of the study.

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): NCT03937869


Contacts
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Contact: Sue Neal 443-740-9379 sueneal@lupin.com

Locations
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United States, California
Site 1004 - Investigational Research Center Recruiting
Long Beach, California, United States, 90806
United States, Florida
Site 1005 - Investigational Research Center Recruiting
Hialeah, Florida, United States, 33016
Site 1009 - Investigational Research Center Recruiting
Miami Lakes, Florida, United States, 33014
Contact: r         
Site 1001 - Investigational Research Center Recruiting
Miami Lakes, Florida, United States, 33161
Site 1010 - Investigational Research Center Recruiting
Sarasota, Florida, United States, 34239
Site 1003 - Investigational Research Center Recruiting
Wellington, Florida, United States, 33414
United States, Michigan
Site 1008 - Investigational Research Center Recruiting
Saginaw, Michigan, United States, 48604
United States, Tennessee
Site 1007 - Investigational Research Center Recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
Site 1006 - Investigational Research Center Recruiting
Frisco, Texas, United States, 75035
Sponsors and Collaborators
Lupin Research Inc
  Study Documents (Full-Text)

Documents provided by Lupin Research Inc:
Study Protocol  [PDF] March 23, 2018
Statistical Analysis Plan  [PDF] March 22, 2019
Informed Consent Form  [PDF] September 12, 2018


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Responsible Party: Lupin Research Inc
ClinicalTrials.gov Identifier: NCT03937869     History of Changes
Other Study ID Numbers: SYM-1219-401
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Adolescents
Vaginal fishy smell
Vaginal itching
off-white milky vaginal discharge

Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Secnidazole
Metronidazole
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents