Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

This study has been terminated.

( The study was stopped by the sponsor based on a non-safety related business priority decision. )

Study NCT00776555 Information provided by Shire Pharmaceutical Development

First Received on October 20, 2008. Last Updated on June 4, 2010 History of Changes

Results First Received: May 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject)
Condition:	Healthy
Interventions:	Drug: Lisdexamfetamine Dimesylate Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine

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
Shire decided to cancel this study on march 31, 2009 due to changes in business priorities. The study termination was not related to any data or safety concerns.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Vyvanse First	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
ADDERALL XR First	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention

Participant Flow: Overall Study

	Vyvanse First	ADDERALL XR First
STARTED	3	0
COMPLETED	0	0
NOT COMPLETED	3	0
Study terminated	3	0

Baseline Characteristics

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Reporting Groups

	Description
Vyvanse First	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
ADDERALL XR First	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention

Baseline Measures

	Vyvanse First	ADDERALL XR First	Total
Number of Participants [units: participants]	3	0	3
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	3	0	3
>=65 years	0	0	0
Gender [units: participants]
Female	1	0	1
Male	2	0	2
Region of Enrollment [units: participants]
United States	3	0	3

Outcome Measures

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1. Primary:

Drug Rating Questionnaire-Subject (DRQ-S), Question 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]

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2. Secondary:

DRQ-S, Question 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]

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3. Secondary:

DRQ-S, Question 3 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]

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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: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

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
Shire decided to cancel this study on march 31, 2009 due to changes in business priorities. The study termination was not related to any data or safety concerns.

Results Point of Contact:

Name/Title: Gerald Tremblay, M.D.
Organization: Shire Pharmaceutical
e-mail: gtremblay@shire.com

No publications provided

Responsible Party:	Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00776555 History of Changes
Other Study ID Numbers:	SPD489-112
Study First Received:	October 20, 2008
Results First Received:	May 5, 2010
Last Updated:	June 4, 2010
Health Authority:	United States: Food and Drug Administration