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

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ClinicalTrials.gov Identifier: NCT03080740
Recruitment Status : Unknown
Verified March 2017 by Guangzhou Yipinhong Pharmaceutical CO.,LTD.
Recruitment status was:  Recruiting
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Guangzhou Yipinhong Pharmaceutical CO.,LTD

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date March 15, 2017
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
Official Title  ICMJE The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
Brief Summary 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
Detailed Description Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE
  • Drug: Clindamycin palmitate hydrochloride dispersible tablet
    300mg, oral after meal, twice daily, a total of 7days
    Other Name: No other Names
  • Drug: Metronidazole Tablet
    400mg, oral after meal , twice daily, a total of 7days
    Other Name: No other Names
Study Arms  ICMJE
  • Active Comparator: Clindamycin palmitate hydrochloride
    Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
    Intervention: Drug: Clindamycin palmitate hydrochloride dispersible tablet
  • Active Comparator: Metronidazole
    Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
    Intervention: Drug: Metronidazole Tablet
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080740
Other Study ID Numbers  ICMJE YPH-BV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Guangzhou Yipinhong Pharmaceutical CO.,LTD
Study Sponsor  ICMJE Guangzhou Yipinhong Pharmaceutical CO.,LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhaohui Liu, MD Peking University First Hospital
Principal Investigator: Shangrong Fan, MD Peking University Shenzhen Hospital
Principal Investigator: Long Sui, MD Affiliated Gynecology and Obstetrics Hospital of Fudan University
Principal Investigator: Ruifang An, MD First Affiliated Hospital of Xi 'an jiaotong University
PRS Account Guangzhou Yipinhong Pharmaceutical CO.,LTD
Verification Date March 2017

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