Bacterial VaginosisPhase 4NCT03080740
The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
A Phase 4 study testing Clindamycin palmitate hydrochloride dispersible tablet and Metronidazole Tablet in people with Bacterial Vaginosis, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Clindamycin palmitate hydrochloride dispersible tablet and Metronidazole Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Dai Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University first hospital
Beijing, 100034
Zhaohui Liu, MD, +86-10-66174284
About this study
Official title: 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
Read the detailed description
Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
- Conditions
- Bacterial Vaginosis
- Being tested
- Clindamycin palmitate hydrochloride dispersible tablet, Metronidazole Tablet
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin palmitate hydrochloride dispersible tabletDrug
Also called No other Names
300mg, oral after meal, twice daily, a total of 7days
Metronidazole TabletDrug
Also called No other Names
400mg, oral after meal , twice daily, a total of 7days
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin palmitate hydrochloride | Active comparator | Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days Receives: Drug: Clindamycin palmitate hydrochloride dispersible tablet |
| Metronidazole | Active comparator | Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days Receives: Drug: Metronidazole Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nugent score
score of Vaginal secretions for Gram stain
Measured: 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;
pH value
Measured: 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
Vaginal cleanliness
Measured: 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
The severity of vulvar itching
Measured: 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
The amount of secretions
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaohui Liu, MD, Study chair, Peking University First HospitalShangrong Fan, MD, Principal investigator, Peking University Shenzhen HospitalLong Sui, MD, Principal investigator, Affiliated Gynecology and Obstetrics Hospital of Fudan UniversityRuifang An, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080740
- Sponsor's protocol ID
- YPH-BV
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03080740
- Acronym / sponsor ID
- YPH-BV
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTDIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin palmitate hydrochloride | Active comparator | Drug: Clindamycin palmitate hydrochloride dispersible tabletClindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days |
| Metronidazole | Active comparator | Drug: Metronidazole TabletMetronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clindamycin palmitate hydrochloride dispersible tabletAlso: No other Names300mg, oral after meal, twice daily, a total of 7days | Drug | Clindamycin palmitate hydrochloride |
| Metronidazole TabletAlso: No other Names400mg, oral after meal , twice daily, a total of 7days | Drug | Metronidazole |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Bacterial Vaginosis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dai Zhang, MD contact
Zhaohui Liu, MD study chair
Peking University First Hospital
Shangrong Fan, MD principal investigator
Peking University Shenzhen Hospital
Long Sui, MD principal investigator
Affiliated Gynecology and Obstetrics Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin palmitate hydrochloride dispersible tablet and Metronidazole Tablet in people with Bacterial Vaginosis, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Liu, MD (+86-10-66174284, 23662161@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.