Trial · NCT00390780
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
NCT00390780, Phase 3, Completed, Valerio Therapeutics; results first posted 2013-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients. Trials, record NCT00390780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00390780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
- NCT number
- NCT00390780
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 578 participants, actual
- Lead sponsor
- Valerio Therapeutics
- Conditions
- HIV Infections
- Interventions
- miconazole Lauriad, Clotrimazole
- First posted
- 2006-10-20
- Last updated
- 2013-09-16
- Results first posted
- 2013-08-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | 17 to 22 days | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. |
| Secondary | Clinical Cure at Day 7 (Using Murray Scoring Scale) | 7 days | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. |
| Secondary | Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) | 17 to 22 days | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score \<2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. |
| Secondary | Clinical Success at Day 7 (Using Murray Scoring Scale) | 7 days | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score \<2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. |
| Secondary | Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale | 17 to 22 days | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level |
| Secondary | Mycological Cure at the Test of Cure Visit (Day 17-22) | 17 to 22 days | Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi. |
| Secondary | Relapse at the Late Post-Therapy Visit (Day 35-38) | 35 to 38 days | "Number of patients" represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., "clinical success") on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a "clinical success" at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under "Not Analyzed-ITT". |
| Secondary | Oral Discomfort Using Visual Analog Scale (VAS) | 14 days | Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort) |
| Secondary | General and Local Tolerability and Oral Discomfort | 14 days | Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14. |
| Secondary | Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet | 14 days | The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | 17 to 22 days | Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)~Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Clinical Cure at Day 7 (Using Murray Scoring Scale) | 7 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) | 17 to 22 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Clinical Success at Day 7 (Using Murray Scoring Scale) | 7 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale | 17 to 22 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Mycological Cure at the Test of Cure Visit (Day 17-22) | 17 to 22 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Relapse at the Late Post-Therapy Visit (Day 35-38) | 35 to 38 days | ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken) | participants | NUMBER |
| SECONDARY | Oral Discomfort Using Visual Analog Scale (VAS) | 14 days | Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication) | units on a scale | MEAN |
| SECONDARY | General and Local Tolerability and Oral Discomfort | 14 days | Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication) | participants | NUMBER |
| SECONDARY | Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet | 14 days | ITT (all randomized patients who took at least 1 dose of study medication) | hours | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Miconazole Lauriad Buccal Tablet | Clinical Cure-ITT | 176 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Clotrimazole Troches | Clinical Cure-ITT | 187 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Miconazole Lauriad Buccal Tablet | Clinical Failure-ITT | 114 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Clotrimazole Troches | Clinical Failure-ITT | 100 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Miconazole Lauriad Buccal Tablet | Clinical Cure-PP | 164 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Clotrimazole Troches | Clinical Cure-PP | 175 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Miconazole Lauriad Buccal Tablet | Clinical Failure-PP | 76 | participants | |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Clotrimazole Troches | Clinical Failure-PP | 61 | participants | |
| Clinical Cure at Day 7 (Using Murray Scoring Scale) | Miconazole Lauriad Buccal Tablet | Clinical Cure-ITT | 67 | participants | |
| Clinical Cure at Day 7 (Using Murray Scoring Scale) | Clotrimazole Troches | Clinical Cure-ITT | 71 | participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Miconazole Lauriad Buccal Tablet | 291 | |
| Overall Study | STARTED | Clotrimazole Troches | 287 | |
| Overall Study | Treatment | Miconazole Lauriad Buccal Tablet | 290 | |
| Overall Study | Treatment | Clotrimazole Troches | 287 | |
| Overall Study | COMPLETED | Miconazole Lauriad Buccal Tablet | 268 | |
| Overall Study | COMPLETED | Clotrimazole Troches | 260 | |
| Overall Study | NOT COMPLETED | Miconazole Lauriad Buccal Tablet | 23 | |
| Overall Study | NOT COMPLETED | Clotrimazole Troches | 27 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Miconazole Lauriad Buccal Tablet | 26 | 290 | 30 |
| other | Diarrhea | Gastrointestinal disorders | Clotrimazole Troches | 23 | 287 | 28 |
| other | Nausea | Gastrointestinal disorders | Miconazole Lauriad Buccal Tablet | 19 | 290 | 25 |
| other | Nausea | Gastrointestinal disorders | Clotrimazole Troches | 22 | 287 | 28 |
| other | Vomiting | Gastrointestinal disorders | Miconazole Lauriad Buccal Tablet | 11 | 290 | 11 |
| other | Vomiting | Gastrointestinal disorders | Clotrimazole Troches | 9 | 287 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | Miconazole Lauriad Buccal Tablet | 5 | 290 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Clotrimazole Troches | 8 | 287 | 10 |
| other | Dry mouth | Gastrointestinal disorders | Miconazole Lauriad Buccal Tablet | 8 | 290 | 8 |
| other | Dry mouth | Gastrointestinal disorders | Clotrimazole Troches | 5 | 287 | 5 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Miconazole Lauriad Buccal Tablet | ||
| Total, all-cause mortality | Clotrimazole Troches | ||
| Total, other adverse events | Miconazole Lauriad Buccal Tablet | 85 | 290 |
| Total, other adverse events | Clotrimazole Troches | 84 | 287 |
| Total, serious adverse events | Miconazole Lauriad Buccal Tablet | 10 | 290 |
| Total, serious adverse events | Clotrimazole Troches | 9 | 287 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Miconazole Lauriad Buccal Tablet vs Clotrimazole Troches: Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet | Trial comparisons |
| Miconazole Lauriad Buccal Tablet vs Clotrimazole Troches: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00390780
GET https://conductscience.org/api/trials/v1/NCT00390780/results?page=2