Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

This study has been completed.

Study NCT00356915 Information provided by GlaxoSmithKline

First Received on July 25, 2006. Last Updated on November 29, 2011 History of Changes

Results First Received: October 1, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Onychomycosis, Toenail Onychomychosis, Toenail Fungus.
Interventions:	Drug: Itraconazole 100mg capsules Drug: Itraconazole 200mg tablets Drug: Placebo tablets

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from clinics in the US, Canada, South America, Ecuador, Dominican Republic, Panama, and Honduras.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened prior to randomization and had to have a positive result from a mycological culture of their toe nail (ie, culture that was positive for dermatophytes). If the culture was negative, they were not randomized to receive treatment and were discontinued from the study.

Reporting Groups

	Description
Itraconazole Tablets	Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Itraconazole Capsules	Itraconazole 100 mg capsules
Placebo Tablets	Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).

Participant Flow: Overall Study

	Itraconazole Tablets	Itraconazole Capsules	Placebo Tablets
STARTED	593	590	198
COMPLETED	517	496	156
NOT COMPLETED	76	94	42
Non compliance	1	2	1
Protocol Violation	2	3	2
Withdrawal by Subject	14	14	10
Lack of Efficacy	0	0	3
Lost to Follow-up	27	34	14
Administrative Decision	0	0	1
Physician Decision	0	2	0
Adverse Event	21	31	8
Miscellaneous reasons	11	8	3

Baseline Characteristics

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Reporting Groups

	Description
Itraconazole Tablets	Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Itraconazole Capsules	Itraconazole 100 mg capsules
Placebo Tablets	Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).

Baseline Measures

	Itraconazole Tablets	Itraconazole Capsules	Placebo Tablets	Total
Number of Participants [units: participants]	593	590	198	1381
Age [units: years] Mean ± Standard Deviation	47.1 ± 11.86	47 ± 12.67	49.2 ± 11.12	47.4 ± 12.13
Gender [units: participants]
Female	441	440	153	1034
Male	152	150	45	347
Race (NIH/OMB) ^[1] [units: Participants]
American Indian or Alaska Native	7	7	4	18
Asian	5	4	2	11
Native Hawaiian or Other Pacific Islander	0	1	0	1
Black or African American	48	48	18	114
White	512	493	169	1174
Unknown or Not Reported	25	41	7	73
Region of Enrollment [units: participants]
Panama	9	9	3	21
United States	527	523	176	1226
Canada	23	21	8	52
Ecuador	6	8	3	17
Honduras	9	9	3	21
Dominican Republic	7	9	2	18
South Africa	12	11	3	26

[1]	Subjects were permitted to select all choices from the list that apply to them with regard to race; ie, multiracial subjects would have checked more than one box and it would have been reported as such. Therefore the total number of subjects reported for race is greater than the number enrolled.

Outcome Measures

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1. Primary:

Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules [ Time Frame: 12 months ]

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2. Primary:

Clinical and Mycological Cure of Target Toenail [ Time Frame: 12 months ]

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3. Secondary:

Clinical Improvement of the Target Toenail [ Time Frame: 12 months ]

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4. Secondary:

Clinical Improvement Compared to Placebo [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Angulo, MD
Organization: Barrier Therapeutics (now part of Stiefel, a GSK company)
phone: 786-999-7038
e-mail: david.a.angulo@stiefel.com

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00356915 History of Changes
Other Study ID Numbers:	BT0300-302-INT
Study First Received:	July 25, 2006
Results First Received:	October 1, 2010
Last Updated:	November 29, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration