Candidiasis, OralPhase 3NCT02184351
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
A Phase 3 study testing Roxanes's clotrimazole troches and Mycelex® troches in people with Candidiasis, Oral, run by Boehringer Ingelheim.
Trial summary
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- Roxanes's clotrimazole troches and Mycelex® troches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Nov 2001
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV positive status
- Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
- Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
- Male or female patients ≥ 18 years
- For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
- Mental status allows comprehension of instructions for troche administration
- Written informed consent
Who cannot join
- Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
- Presence of perioral lesions only
- Use of other antifungal agents within 5 days of enrollment to the study
- Pregnant or lactating women
- History of hypersensitivity to imidazole or azole compounds
- Patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks)
- Patients has received an investigational drug in the last 30 days
- Treatment with another investigational drug is planned within the next 3 weeks
About this study
Official title: A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.
- Conditions
- Candidiasis, Oral
- Being tested
- Roxanes's clotrimazole troches, Mycelex® troches
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxanes's clotrimazole trochesDrug
Mycelex® trochesDrug
| Study group | Role | What they receive |
|---|---|---|
| Roxanes's clotrimazole troches | Experimental | Not described Receives: Drug: Roxanes's clotrimazole troches |
| Mycelex® troches | Active comparator | Not described Receives: Drug: Mycelex® troches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients that have a clinical response assessed by symptoms and physical examination
Measured: Day 21
Secondary outcomes (4)
Incidence of negative fungal cultures of the oropharynx for Candida species
Measured: 7 days after end of treatment
Incidence of negative fungal cultures of the oropharynx for Candida species
Measured: after 14 days of treatment
Clinical response by symptom assessment and physical examination
Measured: after 7 and 14 days of treatment
Assessment of compliance with Treatment by troche Count and Patient interview
Measured: after 7 and 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2001
- Primary completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Single blind
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184351
- Sponsor's protocol ID
- 1190.1
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
- ClinicalTrials.gov ID
- NCT02184351
- Acronym / sponsor ID
- 1190.1
- Conditions
- Candidiasis, Oral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Nov 2001 (actual)
- First posted
- 9 Jul 2014 (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 objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxanes's clotrimazole troches | Experimental | Drug: Roxanes's clotrimazole troches |
| Mycelex® troches | Active comparator | Drug: Mycelex® troches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented HIV positive status
- Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
- Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
- Male or female patients ≥ 18 years
- For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
Key exclusion criteria (8 listed)
- Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
- Presence of perioral lesions only
- Use of other antifungal agents within 5 days of enrollment to the study
- Pregnant or lactating women
- History of hypersensitivity to imidazole or azole compounds
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 |
|---|---|---|
| Roxanes's clotrimazole troches | Drug | Roxanes's clotrimazole troches |
| Mycelex® troches | Drug | Mycelex® troches |
Primary outcome
Percent of patients that have a clinical response assessed by symptoms and physical examination
Time frame: Day 21
4 secondary outcomes
Incidence of negative fungal cultures of the oropharynx for Candida species
Time frame: 7 days after end of treatment
Incidence of negative fungal cultures of the oropharynx for Candida species
Time frame: after 14 days of treatment
Clinical response by symptom assessment and physical examination
Time frame: after 7 and 14 days of treatment
Assessment of compliance with Treatment by troche Count and Patient interview
Time frame: after 7 and 14 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roxanes's clotrimazole troches and Mycelex® troches in people with Candidiasis, Oral, run by Boehringer Ingelheim.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 14 Jul 2014. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of patients that have a clinical response assessed by symptoms and physical examination (time frame: Day 21). 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 14 Jul 2014.