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

March 9, 2017 updated by: Guangzhou Yipinhong Pharmaceutical CO.,LTD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhaohui Liu, MD
  • Phone Number: +86-10-66174284
  • Email: 23662161@qq.com

Study Contact Backup

  • Name: Dai Zhang, MD
  • Phone Number: +86-10-66174284

Study Locations

  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Zhaohui Liu, MD
          • Phone Number: +86-10-66174284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
Drug: Clindamycin palmitate hydrochloride dispersible tablet
300mg, oral after meal, twice daily, a total of 7days
Other Names:
  • No other Names
Active Comparator: Metronidazole
Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
Drug: Metronidazole Tablet
400mg, oral after meal , twice daily, a total of 7days
Other Names:
  • No other Names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Yipinhong Pharmaceutical CO.,LTD

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YPH-BV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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