The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Overview

Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis

Full Title of Study: “The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2017

Detailed Description

Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.

Interventions

  • Drug: Clindamycin palmitate hydrochloride dispersible tablet
    • 300mg, oral after meal, twice daily, a total of 7days
  • Drug: Metronidazole Tablet
    • 400mg, oral after meal , twice daily, a total of 7days

Arms, Groups and Cohorts

  • Active Comparator: Clindamycin palmitate hydrochloride
    • Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
  • Active Comparator: Metronidazole
    • Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days

Clinical Trial Outcome Measures

Primary Measures

  • Nugent score
    • Time Frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
    • score of Vaginal secretions for Gram stain

Secondary Measures

  • The pH of vaginal secretions;
    • Time Frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
    • pH value
  • Leucorrhea routine examination
    • Time Frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
    • Vaginal cleanliness
  • Itching score
    • Time Frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
    • The severity of vulvar itching
  • Vaginal secretions
    • Time Frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
    • The amount of secretions

Participating in This Clinical Trial

Inclusion Criteria

1. Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points 2. Female patients aged 18 to 55 years old. 3. Patients signed the Informed Consent Form(ICF). Exclusion Criteria:

1. Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis. 2. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled. 3. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy. 4. Pregnant or lactating patients. 5. Menopausal women. Menopause definition: perimenopausal women stop menstruations for a year. 6. Women with diabetes. 7. Dependent on alcohol and could not prohibit during the study period. 8. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases. 9. Women allergic to metronidazole, clindamycin. 10. With poor compliance.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Yipinhong Pharmaceutical CO.,LTD
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhaohui Liu, MD, Study Chair, Peking University First Hospital
    • Shangrong Fan, MD, Principal Investigator, Peking University Shenzhen Hospital
    • Long Sui, MD, Principal Investigator, Affiliated Gynecology and Obstetrics Hospital of Fudan University
    • Ruifang An, MD, Principal Investigator, First Affiliated Hospital of Xi ‘an Jiaotong University
  • Overall Contact(s)
    • Zhaohui Liu, MD, +86-10-66174284, 23662161@qq.com

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