Trial · NCT00356915
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
NCT00356915, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2012-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail. Trials, record NCT00356915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00356915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
- NCT number
- NCT00356915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,381 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Onychomycosis
- Interventions
- Itraconazole 100mg capsules, Itraconazole 200mg tablets, Placebo tablets
- First posted
- 2006-07-27
- Last updated
- 2017-02-09
- Results first posted
- 2012-01-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical and Mycological Cure of Target Toenail | 1 year | This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail. |
| Primary | Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules | 12 months | The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule. |
| Secondary | Clinical Improvement of the Target Toenail | 12 months | Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: \>50% dystrophy with onycholysis. |
| Secondary | Clinical Improvement Compared to Placebo | 12 months | Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: \>50% dystrophy with onycholysis. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical and Mycological Cure of Target Toenail | 1 year | Intent to treat (ITT). | Percentage of participants | NUMBER |
| PRIMARY | Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules | 12 months | Intent to treat (ITT). | Percentage of participants | NUMBER |
| SECONDARY | Clinical Improvement of the Target Toenail | 12 months | percentage of participants | NUMBER | |
| SECONDARY | Clinical Improvement Compared to Placebo | 12 months | Intent to treat (ITT) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical and Mycological Cure of Target Toenail | Itraconazole Tablets | 22.3 | Percentage of participants | ||
| Clinical and Mycological Cure of Target Toenail | Placebo Tablets | 1 | Percentage of participants | ||
| Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules | Itraconazole Tablets | 22.3 | Percentage of participants | ||
| Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules | Itraconazole Capsules | 21.7 | Percentage of participants | ||
| Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules | Placebo Tablets | 1.0 | Percentage of participants | ||
| Clinical Improvement of the Target Toenail | Itraconazole Tablets | 33.7 | percentage of participants | ||
| Clinical Improvement of the Target Toenail | Itraconazole Capsules | 29.3 | percentage of participants | ||
| Clinical Improvement Compared to Placebo | Itraconazole Tablets | 33.7 | percentage of participants | ||
| Clinical Improvement Compared to Placebo | Placebo Tablets | 2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Itraconazole Tablets | 593 | |
| Overall Study | STARTED | Itraconazole Capsules | 590 | |
| Overall Study | STARTED | Placebo Tablets | 198 | |
| Overall Study | COMPLETED | Itraconazole Tablets | 517 | |
| Overall Study | COMPLETED | Itraconazole Capsules | 496 | |
| Overall Study | COMPLETED | Placebo Tablets | 156 | |
| Overall Study | NOT COMPLETED | Itraconazole Tablets | 76 | |
| Overall Study | NOT COMPLETED | Itraconazole Capsules | 94 | |
| Overall Study | NOT COMPLETED | Placebo Tablets | 42 |
Source ClinicalTrials.gov
Adverse events156
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 | Hypoacusis | Ear and labyrinth disorders | Itraconazole Tablets - Treatment Period | 19 | 582 | 19 |
| other | Hypoacusis | Ear and labyrinth disorders | Itraconazole Capsules | 16 | 581 | 16 |
| other | Hypoacusis | Ear and labyrinth disorders | Placebo Tablets | 6 | 191 | 6 |
| other | Hypoacusis | Ear and labyrinth disorders | Itraconazole Tablets - Follow-up Period | 19 | 535 | 19 |
| other | Hypoacusis | Ear and labyrinth disorders | Itraconazole Capsules - Follow-up Period | 36 | 515 | 36 |
| other | Hypoacusis | Ear and labyrinth disorders | Placebo Tablets - Follow-up Period | 8 | 168 | 8 |
| serious | Anemia | Blood and lymphatic system disorders | Itraconazole Tablets - Treatment Period | 0 | 582 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Itraconazole Capsules | 0 | 581 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Placebo Tablets | 0 | 191 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Itraconazole Tablets - Follow-up Period | 0 | 535 | 0 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Itraconazole Tablets - Treatment Period | ||
| Total, all-cause mortality | Itraconazole Capsules | ||
| Total, all-cause mortality | Placebo Tablets | ||
| Total, all-cause mortality | Itraconazole Tablets - Follow-up Period | ||
| Total, all-cause mortality | Itraconazole Capsules - Follow-up Period | ||
| Total, all-cause mortality | Placebo Tablets - Follow-up Period | ||
| Total, other adverse events | Itraconazole Tablets - Treatment Period | 19 | 582 |
| Total, other adverse events | Itraconazole Capsules | 16 | 581 |
| Total, other adverse events | Placebo Tablets | 6 | 191 |
| Total, other adverse events | Itraconazole Tablets - Follow-up Period | 19 | 535 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23884486 | 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/NCT00356915
GET https://conductscience.org/api/trials/v1/NCT00356915/events?page=2