NCT00402350View on ClinicalTrials.gov

Staccato Fentanyl Single and Multidose PK

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Breakthrough Pain
Interventions
DRUG

Inhaled Placebo

Inhaled Staccato Placebo, same number of doses as active comparator in that arm

DRUG

Inhaled Fentanyl 25 mcg

Inhaled Staccato Fentanyl, 25 mcg x 1 dose

DRUG

Intravenous Fentanyl 25 mcg

Intravenous Fentanyl 25 mcg, single dose

DRUG

Inhaled Fentanyl 25 mcg x 2

Inhaled Staccato Fentanyl, 25 mcg x 2 doses

DRUG

Inhaled Fentanyl 25 mcg x 4

Inhaled Staccato Fentanyl, 25 mcg x 4 doses

DRUG

Inhaled Fentanyl 25 mcg x 6

Inhaled Staccato Fentanyl, 25 mcg x 6 doses

DRUG

Inhaled Fentanyl 25 mcg x 12

Inhaled Staccato Fentanyl, 25 mcg x 12 doses

Trial Locations (1)

27710

Duke University, Durham

Sponsors
All Listed Sponsors
lead

Alexza Pharmaceuticals, Inc.

INDUSTRY