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Trial Outcomes & Findings for Sublingual Fentanyl for the Management of Breakthrough Pain (NCT NCT02514252)

NCT ID: NCT02514252

Last Updated: 2021-05-18

Results Overview

To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 1 months after discharge from the hospital

Results posted on

2021-05-18

Participant Flow

Patients with advanced cancers aged \>=18 years were recruited from MD Anderson Center.

Participant milestones

Participant milestones
Measure
Fentanyl Sublingual Spray (FSS)
Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sublingual Fentanyl for the Management of Breakthrough Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fentanyl Sublingual Spray (FSS)
n=6 Participants
Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants
Marital status
Married
5 Participants
n=5 Participants
Marital status
Separated/Divorced
1 Participants
n=5 Participants
Education
Some high School
1 Participants
n=5 Participants
Education
Some College
2 Participants
n=5 Participants
Education
Completed College
2 Participants
n=5 Participants
Education
Did not answer
1 Participants
n=5 Participants
Cancer Type
Colon
2 Participants
n=5 Participants
Cancer Type
Gastric
1 Participants
n=5 Participants
Cancer Type
Melanoma
1 Participants
n=5 Participants
Cancer Type
Cholangiocarcinoma
1 Participants
n=5 Participants
Cancer Type
Lymphoma
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 months after discharge from the hospital

Population: Data was not collected due to low accrual and early termination.

To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after discharge from the hospital

Population: Data was not collected due to low accrual and early termination.

To estimate the differences in the pain response between intravenous opioid breakthrough and fentanyl sublingual spray at effective dose. Pain will be assessed in a 0-10 numeric rating scale that assesses pain intensity now, where 0=no pain at all, and 10=worst possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after discharge from the hospital

Population: Data was not collected due to low accrual and early termination.

To determine the safety, tolerability, pattern of use and efficacy of Fentanyl sublingual spray in patients with advanced cancer

Outcome measures

Outcome data not reported

Adverse Events

Fentanyl Sublingual Spray (FSS)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Fentanyl Sublingual Spray (FSS)
n=6 participants at risk
Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.
Nervous system disorders
Drowsiness
50.0%
3/6 • 24 hours after taking fentanyl sublingual spray
Gastrointestinal disorders
Nausea
16.7%
1/6 • 24 hours after taking fentanyl sublingual spray
Skin and subcutaneous tissue disorders
Itching
16.7%
1/6 • 24 hours after taking fentanyl sublingual spray

Additional Information

Suresh K. Reddy, MD/Professor, Palliative Care Med

UT MD Anderson Cancer Center

Phone: (713) 794-5362

Results disclosure agreements

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