NCT03080740

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 6, 2017

Last Update Submit

March 9, 2017

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Clindamycin palmitate hydrochloride

ACTIVE COMPARATOR

Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days

Drug: Clindamycin palmitate hydrochloride dispersible tablet

Metronidazole

ACTIVE COMPARATOR

Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days

Drug: Metronidazole Tablet

Interventions

Clindamycin palmitate hydrochloride dispersible tabletDRUG

300mg, oral after meal, twice daily, a total of 7days

Also known as: No other Names
Clindamycin palmitate hydrochloride
Metronidazole TabletDRUG

400mg, oral after meal , twice daily, a total of 7days

Also known as: No other Names
Metronidazole

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University first hospital

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

clindamycin palmitateMetronidazole

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zhaohui Liu, MD

    Peking University First Hospital

    STUDY CHAIR

  • 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 Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Liu, MD

CONTACT

+86-10-6617428423662161@qq.com

Dai Zhang, MD

CONTACT

+86-10-66174284

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 15, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

CN(1)