Trial · NCT00491764
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
NCT00491764, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2010-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED). Trials, record NCT00491764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00491764
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
- NCT number
- NCT00491764
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 218 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Onychomycosis
- Interventions
- SCH 56592, SCH 56592, SCH 56592, SCH 56592, Terbinafine, Placebo
- First posted
- 2007-06-26
- Last updated
- 2017-04-07
- Results first posted
- 2010-01-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Cure of Onychomycosis at Week 48. | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | Complete cure is defined as negative mycology (negative culture and KOH \[potassium hydroxide\]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis). |
| Secondary | Effective Treatment of Onychomycosis at Week 48. | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or \>5 mm growth of unaffected nail |
| Secondary | Treatment Success of Onychomycosis at Week 48 | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | Treatment success was defined as negative mycology (negative culture and negative KOH) and =\<10% nail involvement. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Cure of Onychomycosis at Week 48. | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication | Participants | NUMBER |
| SECONDARY | Effective Treatment of Onychomycosis at Week 48. | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication | Participants | NUMBER |
| SECONDARY | Treatment Success of Onychomycosis at Week 48 | Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 | This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Cure of Onychomycosis at Week 48. | Posaconazole 100 mg QD for 24 Weeks | 8 | Participants | ||
| Complete Cure of Onychomycosis at Week 48. | Posaconazole 200 mg QD for 24 Weeks. | 20 | Participants | ||
| Complete Cure of Onychomycosis at Week 48. | Posaconazole 400 mg QD for 24 Weeks. | 15 | Participants | ||
| Complete Cure of Onychomycosis at Week 48. | Posaconazole 400 mg QD for 12 Weeks. | 7 | Participants | ||
| Complete Cure of Onychomycosis at Week 48. | Terbinafine 250 mg QD for 12 Weeks. | 13 | Participants | ||
| Complete Cure of Onychomycosis at Week 48. | Placebo for 24 Weeks | 0 | Participants | ||
| Effective Treatment of Onychomycosis at Week 48. | Posaconazole 100 mg QD for 24 Weeks | 9 | Participants | ||
| Effective Treatment of Onychomycosis at Week 48. | Posaconazole 200 mg QD for 24 Weeks. | 24 | Participants | ||
| Effective Treatment of Onychomycosis at Week 48. | Posaconazole 400 mg QD for 24 Weeks. | 16 | Participants | ||
| Effective Treatment of Onychomycosis at Week 48. | Posaconazole 400 mg QD for 12 Weeks. | 11 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Posaconazole 100 mg QD for 24 Weeks | 37 | |
| Overall Study | STARTED | Posaconazole 200 mg QD for 24 Weeks. | 37 | |
| Overall Study | STARTED | Posaconazole 400 mg QD for 24 Weeks. | 36 | |
| Overall Study | STARTED | Posaconazole 400 mg QD for 12 Weeks. | 36 | |
| Overall Study | STARTED | Terbinafine 250 mg QD for 12 Weeks. | 36 | |
| Overall Study | STARTED | Placebo for 24 Weeks | 36 | |
| Overall Study | COMPLETED | Posaconazole 100 mg QD for 24 Weeks | 32 | |
| Overall Study | COMPLETED | Posaconazole 200 mg QD for 24 Weeks. | 30 | |
| Overall Study | COMPLETED | Posaconazole 400 mg QD for 24 Weeks. | 28 | |
| Overall Study | COMPLETED | Posaconazole 400 mg QD for 12 Weeks. | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events252
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 | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Posaconazole 100 mg QD for 24 Weeks | 2 | 36 | 2 |
| other | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Posaconazole 200 mg QD for 24 Weeks | 0 | 37 | 0 |
| other | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Posaconazole 400 mg QD for 24 Weeks | 0 | 36 | 0 |
| other | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Posaconazole 400 mg QD for 12 Weeks | 0 | 36 | 0 |
| other | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Terbinafine 250 mg QD for 12 Weeks | 0 | 36 | 0 |
| other | VENTRICULAR EXTRASYSTOLES | Cardiac disorders | Placebo for 24 Weeks | 0 | 35 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Posaconazole 100 mg QD for 24 Weeks | 0 | 36 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Posaconazole 200 mg QD for 24 Weeks | 2 | 37 | 2 |
| other | DIARRHOEA | Gastrointestinal disorders | Posaconazole 400 mg QD for 24 Weeks | 1 | 36 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Posaconazole 400 mg QD for 12 Weeks | 4 | 36 | 7 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posaconazole 100 mg QD for 24 Weeks | ||
| Total, all-cause mortality | Posaconazole 200 mg QD for 24 Weeks | ||
| Total, all-cause mortality | Posaconazole 400 mg QD for 24 Weeks | ||
| Total, all-cause mortality | Posaconazole 400 mg QD for 12 Weeks | ||
| Total, all-cause mortality | Terbinafine 250 mg QD for 12 Weeks | ||
| Total, all-cause mortality | Placebo for 24 Weeks | ||
| Total, other adverse events | Posaconazole 100 mg QD for 24 Weeks | 26 | 36 |
| Total, other adverse events | Posaconazole 200 mg QD for 24 Weeks | 21 | 37 |
| Total, other adverse events | Posaconazole 400 mg QD for 24 Weeks | 20 | 36 |
| Total, other adverse events | Posaconazole 400 mg QD for 12 Weeks | 18 | 36 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21967490 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00491764
GET https://conductscience.org/api/trials/v1/NCT00491764/events?page=2