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Trial Outcomes & Findings for Dose Finding Posterolateral Thoracotomy Study (NCT NCT00807209)

NCT ID: NCT00807209

Last Updated: 2012-05-15

Results Overview

The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

72 hours

Results posted on

2012-05-15

Participant Flow

Participant milestones

Participant milestones
Measure
High Dose SKY0402
Standard of Care
Low Dose SKY0402
Overall Study
STARTED
1
1
1
Overall Study
COMPLETED
1
1
1
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Finding Posterolateral Thoracotomy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High Dose SKY0402
n=1 Participants
Standard of Care
n=1 Participants
Low Dose SKY0402
n=1 Participants
Total
n=3 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Age Continuous
81 years
STANDARD_DEVIATION 0 • n=5 Participants
75 years
STANDARD_DEVIATION 0 • n=7 Participants
64 years
STANDARD_DEVIATION 0 • n=5 Participants
73.3 years
STANDARD_DEVIATION 0 • n=4 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Region of Enrollment
United States
1 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants
3 participants
n=4 Participants

PRIMARY outcome

Timeframe: 72 hours

The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.

Outcome measures

Outcome measures
Measure
High Dose SKY0402
Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
Standard of Care
n=1 Participants
Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
Low Dose SKY0402
n=1 Participants
Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.
—
0 micrograms
0 micrograms

Adverse Events

High Dose SKY0402

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Low Dose SKY0402

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
High Dose SKY0402
n=1 participants at risk
Standard of Care
n=1 participants at risk
Low Dose SKY0402
n=1 participants at risk
Gastrointestinal disorders
Gas
0.00%
0/1
100.0%
1/1
100.0%
1/1
Gastrointestinal disorders
Diarrhea
0.00%
0/1
100.0%
1/1
0.00%
0/1
Injury, poisoning and procedural complications
Swollen Ankle
0.00%
0/1
100.0%
1/1
0.00%
0/1
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
0.00%
0/1
0.00%
0/1
100.0%
1/1
Respiratory, thoracic and mediastinal disorders
Blood in nasal mucus
0.00%
0/1
0.00%
0/1
100.0%
1/1
Injury, poisoning and procedural complications
Pain
100.0%
1/1
0.00%
0/1
0.00%
0/1
Gastrointestinal disorders
Vomiting
100.0%
1/1
0.00%
0/1
0.00%
0/1
Gastrointestinal disorders
Nausea
100.0%
1/1
0.00%
0/1
0.00%
0/1

Additional Information

Executive Medical Director

Pacira Pharmaceuticals, Inc.

Phone: 203-837-6500

Results disclosure agreements

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