Candidiasis VulvaginitisPhase 2NCT00199264
Efficacy Vulvovaginitis Candida
A Phase 2 study testing Albaconazole oral solution in people with Candidiasis Vulvaginitis, run by J. Uriach and Company.
Trial summary
To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis Vulvaginitis
- What is being tested?
- Albaconazole oral solution
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Oct 2004
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.
Who cannot join
- Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients
About this study
Official title: A Single-Blind, Randomized, Dose-Finding Study Versus Fluconazole to Assess the Efficacy and Tolerability of Five Single Doses of Albaconazole in the Treatment of Acute Non-Recurrent Candida Spp Vulvovaginitis
To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.
Read the detailed description
Multi-center, open-label, randomized study, controlled with fluconazole.
- Conditions
- Candidiasis Vulvaginitis
- Being tested
- Albaconazole oral solution
- Keywords
- antifungal oral therapy, efficacy acute candidiasis vulvaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albaconazole oral solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis VulvaginitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ricardo Negroni, Dr, Study chair, Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199264
- Sponsor's protocol ID
- ICO8ATM/2/03
- Status last verified
- Oct 2003
- First submitted
- 13 Sep 2005
- Last updated
- 3 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Dose-Finding Study Versus Fluconazole to Assess the Efficacy and Tolerability of Five Single Doses of Albaconazole in the Treatment of Acute Non-Recurrent Candida Spp Vulvovaginitis
- ClinicalTrials.gov ID
- NCT00199264
- Acronym / sponsor ID
- ICO8ATM/2/03
- Conditions
- Candidiasis Vulvaginitis
- Keywords
- antifungal oral therapy, efficacy acute candidiasis vulvaginitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Oct 2004
- First posted
- 20 Sep 2005 (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.
To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.
Detailed description
Multi-center, open-label, randomized study, controlled with fluconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.
Key exclusion criteria (1 listed)
- Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients
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 |
|---|---|---|
| Albaconazole oral solution | Drug | – |
Primary outcome
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2006.
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.
Ricardo Negroni, Dr study chair
Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albaconazole oral solution in people with Candidiasis Vulvaginitis, run by J. Uriach and Company.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.. 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 3 Oct 2006.