Trial Outcomes & Findings for Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain (NCT NCT00685295)

NCT ID: NCT00685295

Last Updated: 2017-02-09

Results Overview

Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2017-02-09

Participant Flow

Participant milestones

Measure	Arm 1 / Fentora Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet	Arm 2 / Percocet/Prevacid Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

Baseline characteristics by cohort

Measure	Arm 1 / Fentora n=30 Participants Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet	Arm 2 / Percocet/Prevacid n=30 Participants Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet	Total n=60 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
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 8 • n=5 Participants	30 years STANDARD_DEVIATION 12 • n=7 Participants	30 years STANDARD_DEVIATION 10 • n=5 Participants
Gender Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Gender Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60.0 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)

Outcome measures

Measure	Arm 1 / Fentora n=30 Participants Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet	Arm 2 / Percocet/Prevacid n=30 Participants Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Time to Analgesia	10 minutes Interval 5.0 to 15.0	35 minutes Interval 20.0 to 40.0

PRIMARY outcome

Timeframe: 60 minutes

Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).

Outcome measures

Measure	Arm 1 / Fentora n=30 Participants Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet	Arm 2 / Percocet/Prevacid n=30 Participants Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Pain Reduction	30 Participants	24 Participants

SECONDARY outcome

Timeframe: 120 minutes

Subjects were monitored for any signs of untoward opioid side effects.

Outcome measures

Measure	Arm 1 / Fentora n=30 Participants Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet	Arm 2 / Percocet/Prevacid n=30 Participants Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Occurrence of Untoward Opioid Side Effects	0 Participants	1 Participants

Adverse Events

Arm 1 / Fentora

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 / Percocet/Prevacid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Thomas

Harvard/MGH

Phone: 6177267622

Email: sthomasmd@gmail.com

Results disclosure agreements

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