CandidiasisPhase 3NCT00889356
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
A Phase 3 study testing Clindamycin 100mg and Ketoconazole 400mg and Tetracycline 100mg and Amphotericin B 50mg in people with Candidiasis and Bacterial Vaginosis, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Candidiasis, Bacterial Vaginosis
- What is being tested?
- Clindamycin 100mg and Ketoconazole 400mg and Tetracycline 100mg and Amphotericin B 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mixed-type vaginosis
- Bacterial vaginosis
- Candidiasis
Who cannot join
- Pregnancy
- Vaginal bleeding
- History of recurrent vaginosis
Trial locations and contacts
1 site in 1 country.
Paula Fabrini, MD contact
Brazil1 site
Vox Femina
Jundiaí, São Paulo
Rogerio Bonassi Machado, MD
Rogerio Bonassi Machado, MD
About this study
Official title: Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
- Conditions
- Candidiasis, Bacterial Vaginosis
- Being tested
- Clindamycin 100mg and Ketoconazole 400mg, Tetracycline 100mg and Amphotericin B 50mg
- Medical subject headings
- Candidiasis, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin 100mg and Ketoconazole 400mgDrug
1 vaginal capsule once a day at night
Tetracycline 100mg and Amphotericin B 50mgDrug
One full applicator, once a day at night
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 100mg and Ketoconazole 400mg | Experimental | Not described Receives: Drug: Clindamycin 100mg and Ketoconazole 400mg |
| Tetracycline 100mg and Amphotericin B 50mg | Active comparator | Not described Receives: Drug: Tetracycline 100mg and Amphotericin B 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Measured: 7 days
Secondary outcomes (2)
Tolerability based on adverse events reports and patient's information
Measured: 7 days
Safety based on adverse events reports and laboratory criterion
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rogerio Bonassi Machado, MD, Principal investigator, CRM Regional Council of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889356
- Sponsor's protocol ID
- ZD 002-08
- Status last verified
- Apr 2009
- First submitted
- 24 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
- ClinicalTrials.gov ID
- NCT00889356
- Acronym / sponsor ID
- ZD 002-08
- Conditions
- Candidiasis, Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- 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.
The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 100mg and Ketoconazole 400mg | Experimental | Drug: Clindamycin 100mg and Ketoconazole 400mg |
| Tetracycline 100mg and Amphotericin B 50mg | Active comparator | Drug: Tetracycline 100mg and Amphotericin B 50mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mixed-type vaginosis
- Bacterial vaginosis
- Candidiasis
Key exclusion criteria (3 listed)
- Pregnancy
- Vaginal bleeding
- History of recurrent vaginosis
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 100mg and Ketoconazole 400mg1 vaginal capsule once a day at night | Drug | Clindamycin 100mg and Ketoconazole 400mg |
| Tetracycline 100mg and Amphotericin B 50mgOne full applicator, once a day at night | Drug | Tetracycline 100mg and Amphotericin B 50mg |
Primary outcome
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Time frame: 7 days
2 secondary outcomes
Tolerability based on adverse events reports and patient's information
Time frame: 7 days
Safety based on adverse events reports and laboratory criterion
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
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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.
Paula Fabrini, MD contact
Rogerio Bonassi Machado, MD principal investigator
CRM Regional Council of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clindamycin 100mg and Ketoconazole 400mg and Tetracycline 100mg and Amphotericin B 50mg in people with Candidiasis and Bacterial Vaginosis, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
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 3 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 28 Apr 2009. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Rogerio Bonassi Machado, MD (+55 11 4521-6466, rogeriobonassi@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on cure rate evaluated by clinical and laboratory criteria. (time frame: 7 days). 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 28 Apr 2009.