POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00423267

First received: January 17, 2007

Last updated: August 12, 2010

Last verified: August 2010

History of Changes

Results First Received: May 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Coccidioidomycosis
Interventions:	Drug: Posaconazole Drug: Fluconazole

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
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Reporting Groups

	Description
Posaconazole	Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
Fluconazole	Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.

Description

Posaconazole

Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.

Fluconazole

Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.

Participant Flow for 2 periods

Period 1: Period A

	Posaconazole	Fluconazole
STARTED	9	7
COMPLETED	7	6
NOT COMPLETED	2	1
Withdrawal by Subject	0	1
Non-compliance with protocol	1	0
Administrative	1	0

Period 2: Period B

	Posaconazole	Fluconazole
STARTED	12	0
COMPLETED	12	0
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Posaconazole	Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
Fluconazole	Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
Total	Total of all reporting groups

Baseline Measures

	Posaconazole	Fluconazole	Total
Number of Participants [units: participants]	9	7	16
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	7	7	14
>=65 years	2	0	2
Gender [units: participants]
Female	4	2	6
Male	5	5	10

Outcome Measures

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1. Primary:

Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A [ Time Frame: 12 months ]

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2. Primary:

Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B [ Time Frame: 12 months ]

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3. Secondary:

Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A [ Time Frame: 12 months ]

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4. Secondary:

Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B [ Time Frame: 12 months ]

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5. Secondary:

Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A [ Time Frame: 12 months ]

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6. Secondary:

Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B [ Time Frame: 12 months ]

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7. Secondary:

Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A [ Time Frame: 12 months ]

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8. Secondary:

Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B [ 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. Restriction Description: The investigator agrees not to publish or present any interim results of the study without the Sponsor's prior written consent. The investigator further agrees to provide review copies to the Sponsor 45 days prior to submission for publication or presentation. The sponsor has the right to review and comment. If the parties disagree concerning the appropriateness of the data analysis and presentation, and/or confidentiality, investigator agrees to meet with the sponsor to discuss and resolve.

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 Disclsoure 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:	NCT00423267 History of Changes
Other Study ID Numbers:	P04558
Study First Received:	January 17, 2007
Results First Received:	May 27, 2010
Last Updated:	August 12, 2010
Health Authority:	United States: Food and Drug Administration

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