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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080740
• Other study ID #: YPH-BV
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2017
• Last updated: March 9, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Contact: Zhaohui Liu, MD
• Phone: +86-10-66174284
• Email: 23662161[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Peking University first hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Yipinhong Pharmaceutical CO.,LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nugent score	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	The pH of vaginal secretions;	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.
Secondary	Leucorrhea routine examination	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.
Secondary	Itching score	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.
Secondary	Vaginal secretions	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.