Trial · NCT00791219
Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
NCT00791219, Phase 2, Completed, Halcygen Pharmaceuticals Limited; results first posted 2020-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis. Trials, record NCT00791219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00791219
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
- NCT number
- NCT00791219
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 175 participants, actual
- Lead sponsor
- Halcygen Pharmaceuticals Limited
- Conditions
- Onychomycosis
- Interventions
- SUBA-itraconazole, Itraconazole, Placebo
- First posted
- 2008-11-14
- Last updated
- 2020-08-25
- Results first posted
- 2020-08-25
- Limitations and caveats
Subjects were followed for 12 weeks after the 12 week treatment period, typically subjects would be followed for at least 24 weeks post-treatment to allow sufficient time for the nail to grow out and therefore maximizing rates of clinical cure
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Therapeutic Cure" at the End of Study Visit (Week 24) | Week 24 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated |
| Primary | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Clinical Cure" at the End of Study Visit (Week 24) | Week 24 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Clinical Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated |
| Primary | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Mycological Cure" at the End of Study Visit (Week 24) | Week 24 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Mycological Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated |
| Secondary | The Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12). | Week 12 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated |
| Secondary | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Clinical Cure" at the End of Study Visit (Week 12) | week 12 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated |
| Secondary | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Mycological Cure" at the End of Study Visit (Week 12) | week 12 | If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated |
| Other | Superiority of Test Treatment Over Placebo for Mycological Cure | week 6 | All primary and secondary endpoints were tested for superiority against Placebo. The intent to treat (ITT) was used for all superiority testing. For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Therapeutic Cure at the End of Study Visit (Week 24) | Week 24 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Clinical Cure at the End of Study Visit (Week 24) | Week 24 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Mycological Cure at the End of Study Visit (Week 24) | Week 24 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure at the End of Treatment Visit (Week 12) 12). | Week 12 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Clinical Cure at the End of Study Visit (Week 12) | week 12 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Mycological Cure at the End of Study Visit (Week 12) | week 12 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Superiority of Test Treatment Over Placebo for Mycological Cure | week 6 | The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Therapeutic Cure at the End of Study Visit (Week 24) | Placebo | 0 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Therapeutic Cure at the End of Study Visit (Week 24) | Test | 8 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Therapeutic Cure at the End of Study Visit (Week 24) | Reference | 3 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Clinical Cure at the End of Study Visit (Week 24) | Placebo | 0 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Clinical Cure at the End of Study Visit (Week 24) | Test | 12 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Clinical Cure at the End of Study Visit (Week 24) | Reference | 4 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Mycological Cure at the End of Study Visit (Week 24) | Placebo | 1 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Mycological Cure at the End of Study Visit (Week 24) | Test | 25 | Participants | ||
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a Mycological Cure at the End of Study Visit (Week 24) | Reference | 22 | Participants | ||
| The Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure at the End of Treatment Visit (Week 12) 12). | Placebo | 0 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 24 | |
| Overall Study | STARTED | Test | 76 | |
| Overall Study | STARTED | Reference | 75 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | COMPLETED | Test | 60 | |
| Overall Study | COMPLETED | Reference | 61 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Test | 16 | |
| Overall Study | NOT COMPLETED | Reference | 14 |
Source ClinicalTrials.gov
Adverse events102
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 | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 24 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Test | 2 | 76 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Reference | 0 | 75 | 0 |
| other | Acoustic Stimulation Tests Abnormal | Ear and labyrinth disorders | Placebo | 0 | 24 | 0 |
| other | Acoustic Stimulation Tests Abnormal | Ear and labyrinth disorders | Test | 2 | 76 | 2 |
| other | Acoustic Stimulation Tests Abnormal | Ear and labyrinth disorders | Reference | 3 | 75 | 3 |
| other | Alanine Aminotransferase Increased | Investigations | Placebo | 0 | 24 | 0 |
| other | Alanine Aminotransferase Increased | Investigations | Test | 3 | 76 | 3 |
| other | Alanine Aminotransferase Increased | Investigations | Reference | 2 | 75 | 2 |
| other | Arthropod Bite | Injury, poisoning and procedural complications | Placebo | 1 | 24 | 1 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 24 |
| Total, all-cause mortality | Test | 0 | 76 |
| Total, all-cause mortality | Reference | 0 | 75 |
| Total, other adverse events | Placebo | 13 | 24 |
| Total, other adverse events | Test | 42 | 76 |
| Total, other adverse events | Reference | 35 | 75 |
| Total, serious adverse events | Placebo | 0 | 24 |
| Total, serious adverse events | Test | 2 | 76 |
| Total, serious adverse events | Reference | 1 | 75 |
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 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/NCT00791219
GET https://conductscience.org/api/trials/v1/NCT00791219/results?page=2