Trial Outcomes & Findings for Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution (NCT NCT00776555)

Results Overview

Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

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

Results posted on

2021-06-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	3	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Study terminated	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vyvanse First n=3 Participants 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	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	—	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: Analysis not performed because of the study's premature termination.

Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: Analysis not performed because of the study's premature termination.

Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: Analysis not performed because of the study's premature termination.

Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Outcome measures

Outcome data not reported

Adverse Events

Vyvanse First

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

ADDERALL XR First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vyvanse First n=3 participants at risk 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
Nervous system disorders Headache	33.3% 1/3 • 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. Note: At the time of the premature termination, only 3 participants had been enrolled into this study. All 3 participants were randomized to receive VYVANSE in Period 1 of this study, and ADDERALL XR in Period 2 of this study. None of the study participants advanced to Period 2, therefore none received ADDERALL XR.	— 0/0 • 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. Note: At the time of the premature termination, only 3 participants had been enrolled into this study. All 3 participants were randomized to receive VYVANSE in Period 1 of this study, and ADDERALL XR in Period 2 of this study. None of the study participants advanced to Period 2, therefore none received ADDERALL XR.
Infections and infestations Upper respiratory infection	33.3% 1/3 • 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. Note: At the time of the premature termination, only 3 participants had been enrolled into this study. All 3 participants were randomized to receive VYVANSE in Period 1 of this study, and ADDERALL XR in Period 2 of this study. None of the study participants advanced to Period 2, therefore none received ADDERALL XR.	— 0/0 • 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. Note: At the time of the premature termination, only 3 participants had been enrolled into this study. All 3 participants were randomized to receive VYVANSE in Period 1 of this study, and ADDERALL XR in Period 2 of this study. None of the study participants advanced to Period 2, therefore none received ADDERALL XR.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER