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

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ClinicalTrials.gov Identifier: NCT03080740
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Clindamycin palmitate hydrochloride dispersible tablet Drug: Metronidazole Tablet Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017


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 Name: 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 Name: No other Names




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080740


Contacts
Contact: Zhaohui Liu, MD +86-10-66174284 23662161@qq.com
Contact: Dai Zhang, MD +86-10-66174284

Locations
China
Peking University first hospital Recruiting
Beijing, China, 100034
Contact: Zhaohui Liu, MD    +86-10-66174284      
Sponsors and Collaborators
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

Responsible Party: Guangzhou Yipinhong Pharmaceutical CO.,LTD
ClinicalTrials.gov Identifier: NCT03080740     History of Changes
Other Study ID Numbers: YPH-BV
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Clindamycin palmitate
Clindamycin phosphate
Metronidazole
Clindamycin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action