Trial Outcomes & Findings for An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement (NCT NCT00859313)

Results Overview

Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

12 hours

Results posted on

2012-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Sufentanil NanoTab PCA System/15 Mcg 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sufentanil NanoTab PCA System/15 Mcg 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
Overall Study Lack of Efficacy	2
Overall Study Adverse Event	1
Overall Study staff error	1

Baseline Characteristics

An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sufentanil NanoTab PCA System/15 Mcg n=30 Participants 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age Continuous	65.7 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.

Outcome measures

Outcome measures
Measure	Sufentanil NanoTab PCA System/15 Mcg n=30 Participants 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
Percent of Patients Without Device Failure	100 percent

Adverse Events

Sufentanil NanoTab PCA System/15 Mcg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sufentanil NanoTab PCA System/15 Mcg n=30 participants at risk 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
Gastrointestinal disorders nausea	16.7% 5/30 • Number of events 5
Gastrointestinal disorders vomiting	20.0% 6/30 • Number of events 6

Additional Information

Dr. Pamela Palmer

AcelRx Pharmaceuticals, Inc.

Phone: 650-216-3504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee no publication without prior written consent
Publication restrictions are in place

Restriction type: OTHER