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

Primary Purpose

Bacterial Vaginosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clindamycin palmitate hydrochloride dispersible tablet
Metronidazole Tablet
Sponsored by
Guangzhou Yipinhong Pharmaceutical CO.,LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University first hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clindamycin palmitate hydrochloride

Metronidazole

Arm Description

Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days

Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days

Outcomes

Primary Outcome Measures

Nugent score
score of Vaginal secretions for Gram stain

Secondary Outcome Measures

The pH of vaginal secretions;
pH value
Leucorrhea routine examination
Vaginal cleanliness
Itching score
The severity of vulvar itching
Vaginal secretions
The amount of secretions

Full Information

First Posted
March 6, 2017
Last Updated
March 9, 2017
Sponsor
Guangzhou Yipinhong Pharmaceutical CO.,LTD
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1. Study Identification

Unique Protocol Identification Number
NCT03080740
Brief Title
The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
Official Title
The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Yipinhong Pharmaceutical CO.,LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin palmitate hydrochloride
Arm Type
Active Comparator
Arm Description
Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
Intervention Type
Drug
Intervention Name(s)
Clindamycin palmitate hydrochloride dispersible tablet
Other Intervention Name(s)
No other Names
Intervention Description
300mg, oral after meal, twice daily, a total of 7days
Intervention Type
Drug
Intervention Name(s)
Metronidazole Tablet
Other Intervention Name(s)
No other Names
Intervention Description
400mg, oral after meal , twice daily, a total of 7days
Primary Outcome Measure Information:
Title
Nugent score
Description
score of Vaginal secretions for Gram stain
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.
Secondary Outcome Measure Information:
Title
The pH of vaginal secretions;
Description
pH value
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.
Title
Leucorrhea routine examination
Description
Vaginal cleanliness
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.
Title
Itching score
Description
The severity of vulvar itching
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.
Title
Vaginal secretions
Description
The amount of 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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points Female patients aged 18 to 55 years old. Patients signed the Informed Consent Form(ICF). Exclusion Criteria: Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy. Pregnant or lactating patients. Menopausal women. Menopause definition: perimenopausal women stop menstruations for a year. Women with diabetes. Dependent on alcohol and could not prohibit during the study period. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases. Women allergic to metronidazole, clindamycin. With poor compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Liu, MD
Phone
+86-10-66174284
Email
23662161@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dai Zhang, MD
Phone
+86-10-66174284
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Liu, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shangrong Fan, MD
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Long Sui, MD
Organizational Affiliation
Affiliated Gynecology and Obstetrics Hospital of Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruifang An, MD
Organizational Affiliation
First Affiliated Hospital of Xi 'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University first hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Liu, MD
Phone
+86-10-66174284

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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