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

Phase 4

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Clindamycin palmitate hydrochloride dispersible tablet; Drug: Metronidazole Tablet

• Registration Number: NCT03080740
• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

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 Timeline

• Study Start: 2016-07
• Status Verified: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-15
• Last Update Posted: 2017-03-15
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clindamycin palmitate hydrochloride	Clindamycin palmitate hydrochloride dispersible tablet	Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
Metronidazole	Metronidazole Tablet	Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days

Primary Outcome Measures

Name	Time	Method
Nugent score	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 Outcome Measures

Name	Time	Method
Itching score	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
Leucorrhea routine examination	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
The pH of vaginal 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.	pH value
Vaginal 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.	The amount of secretions

Trial Locations

Locations (1)

Peking University first hospital; 🇨🇳 Beijing, China