Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Vaginoses | Drug: Secnidazole | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
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 28, 2018 |
Actual Primary Completion Date : | November 5, 2020 |
Actual Study Completion Date : | November 5, 2020 |
Arm | Intervention/treatment |
---|---|
Single dose Solosec (secnidazole) 2g oral
Solosec 2 grams, oral
|
Drug: Secnidazole
One dose
Other Name: Solosec™
|
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 |
Inclusion Criteria:
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Exclusion Criteria:
United States, California | |
Site 1004 - Investigational Research Center | |
Long Beach, California, United States, 90806 | |
United States, Florida | |
Site 1005 - Investigational Research Center | |
Hialeah, Florida, United States, 33016 | |
Site 1001 - Investigational Research Center | |
Miami Lakes, Florida, United States, 33161 | |
Site 1010 - Investigational Research Center | |
Sarasota, Florida, United States, 34239 | |
Site 1013 | |
Tampa, Florida, United States, 33613 | |
United States, Kentucky | |
Site 1011 - Investigational Research Center | |
Bardstown, Kentucky, United States, 40004 | |
United States, Michigan | |
Site 1008 - Investigational Research Center | |
Saginaw, Michigan, United States, 48604 | |
United States, Tennessee | |
Site 1007 - Investigational Research Center | |
Memphis, Tennessee, United States, 38104 | |
United States, Texas | |
Site 1006 - Investigational Research Center | |
Frisco, Texas, United States, 75035 |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | April 22, 2019 | ||||||
First Posted Date ICMJE | May 6, 2019 | ||||||
Last Update Posted Date | December 19, 2020 | ||||||
Actual Study Start Date ICMJE | November 28, 2018 | ||||||
Actual Primary Completion Date | November 5, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
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 | Allocation: N/A 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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | November 5, 2020 | ||||||
Actual Primary Completion Date | November 5, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 12 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
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 |
|
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IPD Sharing Statement ICMJE |
|
||||||
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 | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |