A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

This study has been completed.

Study NCT00491764 Information provided by Schering-Plough

First Received on June 25, 2007. Last Updated on December 23, 2009 History of Changes

Results First Received: December 23, 2009

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
Interventions:	Drug: SCH 56592 Drug: Terbinafine Drug: Placebo

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 690 subjects were enrolled in the study and screened for eligibility. A total of 472 were screen-failures, leaving 218 subjects randomized to treatment.

Reporting Groups

	Description
Posaconazole 100 mg QD for 24 Weeks	Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
Posaconazole 200 mg QD for 24 Weeks.	Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole 400 mg QD for 24 Weeks.	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole 400 mg QD for 12 Weeks.	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine 250 mg QD for 12 Weeks.	Terbinafine 250 mg QD for 12 weeks.
Placebo for 24 Weeks	Placebo for 24 weeks.

Participant Flow: Overall Study

	Posaconazole 100 mg QD for 24 Weeks	Posaconazole 200 mg QD for 24 Weeks.	Posaconazole 400 mg QD for 24 Weeks.	Posaconazole 400 mg QD for 12 Weeks.	Terbinafine 250 mg QD for 12 Weeks.	Placebo for 24 Weeks
STARTED	37	37	36	36	36	36
COMPLETED	32	30	28	28	33	27
NOT COMPLETED	5	7	8	8	3	9
Adverse Event	1	2	4	4	0	1
Lost to Follow-up	0	1	0	1	0	3
Withdrawal by Subject	2	3	1	2	2	4
Non Compliance with the Protocol	1	0	0	0	0	0
Did not Meet Protocol Eligibility	0	1	1	0	1	1
Administrative	1	0	2	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Posaconazole 100 mg QD for 24 Weeks	Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
Posaconazole 200 mg QD for 24 Weeks.	Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole 400 mg QD for 24 Weeks.	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole 400 mg QD for 12 Weeks.	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine 250 mg QD for 12 Weeks.	Terbinafine 250 mg QD for 12 weeks.
Placebo for 24 Weeks	Placebo for 24 weeks.

Baseline Measures

	Posaconazole 100 mg QD for 24 Weeks	Posaconazole 200 mg QD for 24 Weeks.	Posaconazole 400 mg QD for 24 Weeks.	Posaconazole 400 mg QD for 12 Weeks.	Terbinafine 250 mg QD for 12 Weeks.	Placebo for 24 Weeks	Total
Number of Participants [units: participants]	37	37	36	36	36	36	218
Age [units: years] Mean ± Standard Deviation	49.0 ± 13.0	53.6 ± 10.8	49.9 ± 13.2	53.5 ± 11.8	50.1 ± 12.2	48.4 ± 14.8	50.8 ± 12.7
Gender [units: participants]
Female	10	6	8	7	7	7	45
Male	27	31	28	29	29	29	173

Outcome Measures

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1. Primary:

Complete Cure of Onychomycosis at Week 48. [ Time Frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 ]

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2. Secondary:

Effective Treatment of Onychomycosis at Week 48. [ Time Frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 ]

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3. Secondary:

Treatment Success of Onychomycosis at Week 48 [ Time Frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48 ]

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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. Restriction Description: PI must provide to sponsor 45 days prior to submission for publication/presentation, review copies of content to be presented that contains any results of the study. The sponsor has the right to review/comment with regard to proprietary information, accuracy, and fair balance. If disagreements arise concerning appropriateness of content to be presented, investigator must meet with sponsor prior to submission for publication to make good faith efforts to discuss/resolve any issues/disagreement.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00491764 History of Changes
Other Study ID Numbers:	P05082
Study First Received:	June 25, 2007
Results First Received:	December 23, 2009
Last Updated:	December 23, 2009
Health Authority:	United States: Food and Drug Administration