You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR SECNIDAZOLE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Secnidazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01019083 ↗ Studies of Immune Responses to Orally Administered Vaccines in Developing Country Completed Göteborg University Phase 1/Phase 2 2008-02-01 The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT01019083 ↗ Studies of Immune Responses to Orally Administered Vaccines in Developing Country Completed International Centre for Diarrhoeal Disease Research, Bangladesh Phase 1/Phase 2 2008-02-01 The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT02111629 ↗ Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge Completed Universidad Nacional de Colombia Phase 3 2012-05-01 Genital tract infections (GTIs) have increased in the past decade and there is an association between sexually transmitted infections (STIs) and other infections like bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in places with no access to laboratory diagnostic tests. Justification. In patients with syndrome of vaginal discharge, an effective treatment against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for syndromic management of symptomatic vaginal discharge the combination of fluconazole and secnidazole could be used. No studies evaluating this combination were found in the literature reviewed. Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management of symptomatic vaginal discharge. Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and safety of the combination of fluconazole and secnidazole for the treatment of symptomatic vaginal discharge. The participants will be sexually active women with lower genital tract symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character of the study, no a priori hypothesis is considered. A consecutive convenience sample size of 100 symptomatic patients is calculated. The statistical analysis will be performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of central tendency and dispersion appropriate for the distribution of the variables will be calculated. The study has been submitted and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All women must sign a written informed consent form agreeing to voluntarily participate in the study.
NCT02147899 ↗ A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis Completed Symbiomix Therapeutics Phase 2 2014-05-01 The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
NCT02452866 ↗ Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 Completed Symbiomix Therapeutics Phase 3 2015-06-01 This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
NCT03935217 ↗ A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis Completed Lupin Research Inc Phase 3 2019-04-23 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.
NCT03937869 ↗ Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV Completed Lupin Research Inc Phase 4 2018-11-28 A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Secnidazole

Condition Name

Condition Name for Secnidazole
Intervention Trials
Bacterial Vaginosis 2
Trichomonas Infection 1
Typhoid 1
Vaginal Discharge 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Secnidazole
Intervention Trials
Vaginosis, Bacterial 4
Vaginal Diseases 4
Cholera 1
Trichomonas Infections 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Secnidazole

Trials by Country

Trials by Country for Secnidazole
Location Trials
United States 51
Bangladesh 1
Colombia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Secnidazole
Location Trials
Tennessee 4
Florida 4
California 3
Alabama 3
Virginia 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Secnidazole

Clinical Trial Phase

Clinical Trial Phase for Secnidazole
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2/Phase 3 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Secnidazole
Clinical Trial Phase Trials
Completed 6
Recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Secnidazole

Sponsor Name

Sponsor Name for Secnidazole
Sponsor Trials
Symbiomix Therapeutics 2
Lupin Research Inc 2
Göteborg University 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Secnidazole
Sponsor Trials
Industry 5
Other 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Secnidazole: Clinical Trials, Market Analysis, and Projections

Introduction

Secnidazole, a nitroimidazole antibiotic, has been gaining significant attention for its efficacy in treating various infections, particularly bacterial vaginosis (BV) and trichomoniasis. Here, we delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials for Secnidazole

Bacterial Vaginosis (BV)

Secnidazole has been extensively studied for its effectiveness in treating BV. Two pivotal clinical trials, SYM 1219-201 and SYM 1219-301, were conducted to evaluate its efficacy and safety.

  • Trial Outcomes: In these trials, secnidazole demonstrated a significant treatment effect compared to placebo. For instance, in Trial SYM 1219-201, 67.7% of patients who received a 2g dose of secnidazole achieved clinical response, compared to 17.7% in the placebo group[3][4].
  • Efficacy Endpoints: The primary endpoint was the Clinical Response evaluated at the Test of Cure (TOC) visit, which included normal vaginal discharge, a negative Whiff test, and fewer than 20% clue cells. Secnidazole showed a treatment difference of 50.0% (95% CI: 33.4, 66.7) compared to placebo[3][4].

Trichomoniasis

Recently, secnidazole has been investigated for its efficacy in treating trichomoniasis, the most prevalent non-viral sexually transmitted infection.

  • Trial Design: A multicenter, randomized, double-blind, placebo-controlled Phase 3 trial was conducted involving 147 female patients. Participants were randomized to receive either a single 2g dose of secnidazole or placebo[1][2].
  • Trial Outcomes: The trial showed a microbiological cure rate of 92.2% (95% CI: 82.7%–97.4%) in the modified intention-to-treat (mITT) population for secnidazole, compared to 1.5% (95% CI: 0%–8.0%) for placebo. In the per-protocol population, the cure rate was 94.9% (95% CI: 85.9%–98.9%) for secnidazole versus 1.7% (95% CI: 0%–8.9%) for placebo[1][2].

Safety Profile of Secnidazole

Adverse Events

Secnidazole has been generally well-tolerated in clinical trials.

  • Common Adverse Events: The most frequently reported treatment-emergent adverse events (TEAEs) include vulvovaginal candidiasis and nausea, each occurring in 2.7% of patients. No serious TEAEs were observed in the trials for both BV and trichomoniasis[1][2][3].
  • Special Populations: The drug has shown efficacy and safety in women with HIV and those with a history of multiple BV episodes. However, its safety in pediatric patients and pregnant women has not been established[2][3].

Market Analysis

Current Market Size

The global secnidazole market has been growing steadily, driven by the increasing prevalence of BV and trichomoniasis, as well as the drug's efficacy and convenience.

  • Market Size: As of 2018, the global secnidazole market was valued at a significant amount and is projected to expand at a compound annual growth rate (CAGR) from 2019 to 2025[5].

Market Drivers

Several factors are driving the growth of the secnidazole market:

  • Efficacy and Convenience: Secnidazole's single-dose regimen offers a convenient and effective treatment option, which improves patient compliance compared to multi-dose treatments[1][3][4].
  • Increasing Prevalence: The rising incidence of BV and trichomoniasis, particularly among high-risk populations such as women with HIV, is driving the demand for effective treatments[2].

Market Challenges

Despite the positive outlook, there are challenges to consider:

  • Competition: The market for antibiotics and antiprotozoal drugs is competitive, with established treatments like metronidazole and tinidazole. Secnidazole must differentiate itself through its efficacy, safety, and convenience[2][3].
  • Regulatory Approvals: While secnidazole has received FDA approval for BV, its approval for trichomoniasis is pending. Regulatory hurdles can impact market growth[1][3].

Market Projections

Future Growth

The secnidazole market is expected to grow significantly over the next few years.

  • CAGR: The market is projected to expand at a CAGR from 2019 to 2025, driven by increasing demand and expanding indications[5].
  • New Indications: The potential approval for trichomoniasis and other infections could further boost the market size and share of secnidazole[1][2].

Geographic Expansion

The market for secnidazole is not limited to the United States; it has global potential.

  • Global Reach: As the drug gains approvals in other regions, its market size is expected to increase, particularly in areas with high prevalence rates of BV and trichomoniasis[5].

Key Takeaways

  • Efficacy: Secnidazole has demonstrated high cure rates for both BV and trichomoniasis in clinical trials.
  • Safety: The drug is generally well-tolerated with minimal serious adverse events.
  • Market Growth: The market is expected to grow due to the drug's convenience, efficacy, and expanding indications.
  • Regulatory Approvals: Pending approvals for new indications will be crucial for market expansion.

FAQs

What is secnidazole used for?

Secnidazole is used for the treatment of bacterial vaginosis (BV) and is under investigation for the treatment of trichomoniasis.

How effective is secnidazole in treating BV?

Secnidazole has shown a clinical response rate of 67.7% in treating BV, significantly higher than the placebo group[3][4].

What are the common adverse events associated with secnidazole?

The most commonly reported adverse events include vulvovaginal candidiasis and nausea, each occurring in 2.7% of patients[1][2][3].

Is secnidazole approved for trichomoniasis?

Secnidazole is not yet approved for trichomoniasis but has shown promising results in clinical trials and is pending FDA approval[1][2].

What is the projected market growth for secnidazole?

The global secnidazole market is projected to expand at a CAGR from 2019 to 2025, driven by increasing demand and expanding indications[5].

Sources

  1. Lupin Announces Positive Topline Results From its Phase 3 Study of Single-Dose Solosec (Secnidazole) for the Treatment of Trichomoniasis. PR Newswire.
  2. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis. Clinical Infectious Diseases.
  3. 209363Orig1s000 - accessdata.fda.gov. FDA.
  4. Drug Trials Snapshot: SOLOSEC - FDA. FDA.
  5. Secnidazole Market Size, Share, Trend and Forecast to 2025. Prof Research.

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.