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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

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE November 12, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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
  • 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.
  • Investigator Clinical Assessment [ Time Frame: At TOC visit study day 7-14 ]
    Investigator's opinion of the need for additional BV treatment. (Yes/No)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginoses
Intervention  ICMJE Drug: Secnidazole
One dose
Other Name: Solosec™
Study Arms  ICMJE Single dose Solosec (secnidazole) 2g oral
Solosec 2 grams, oral
Intervention: Drug: Secnidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: must be adolescent females ages 12-17 years of age
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sue Neal 443-740-9379 sueneal@lupin.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937869
Other Study ID Numbers  ICMJE SYM-1219-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lupin Research Inc
Study Sponsor  ICMJE Lupin Research Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lupin Research Inc
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP