- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080740
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
-
-
-
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:
- 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.
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
|
300mg, oral after meal, twice daily, a total of 7days
Other Names:
|
Active Comparator: Metronidazole
Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
|
400mg, oral after meal , twice daily, a total of 7days
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.
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
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Vaginal Diseases
- Vaginosis, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
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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