Trial Outcomes & Findings for An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis (NCT NCT01774929)

Last Updated: 2013-05-22

Results Overview

The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Day 15

Results posted on

2013-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Transdermal Therapeutic System (TTS)-Fentanyl TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study STARTED	35
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Transdermal Therapeutic System (TTS)-Fentanyl TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study Adverse Event	3

Baseline Characteristics

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=35 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Age Continuous	66.03 Years STANDARD_DEVIATION 8.25 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Pain Intensity Score by Visual Analog Scale (VAS)	7.86 Centimeter [cm] STANDARD_DEVIATION 2.02 • n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. "N" signifies those participants who were evaluated for this outcome measure.

The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.

Outcome measures

Outcome measures
Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=33 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Pain Intensity Score at Day 15	6.61 cm Standard Deviation 2.93

PRIMARY outcome

Timeframe: Day 30

Population: ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. "N" signifies those participants who were evaluated for this outcome measure.

The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.

Outcome measures

Outcome measures
Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=33 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Pain Intensity Score at Day 30	6.00 cm Standard Deviation 3.31

SECONDARY outcome

Timeframe: Baseline, Day 15 and Day 30

The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.

Outcome measures

Outcome measures
Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=33 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 Baseline	17.04 Units on a scale Standard Deviation 4.38
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 Day 15	14.84 Units on a scale Standard Deviation 5.40
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 Day 30	13.41 Units on a scale Standard Deviation 6.44

Adverse Events

Transdermal Therapeutic System (TTS)-Fentanyl

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=35 participants at risk TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
General disorders Vomiting	5.7% 2/35 • Baseline up to Day 30
General disorders Nausea	20.0% 7/35 • Baseline up to Day 30
General disorders Constipation	14.3% 5/35 • Baseline up to Day 30
General disorders Abdominal pain	2.9% 1/35 • Baseline up to Day 30
General disorders Dyspepsia	2.9% 1/35 • Baseline up to Day 30
General disorders Drowsiness	20.0% 7/35 • Baseline up to Day 30
General disorders Headache	2.9% 1/35 • Baseline up to Day 30
General disorders Itching	8.6% 3/35 • Baseline up to Day 30
General disorders Irritate	2.9% 1/35 • Baseline up to Day 30
General disorders Fatigue	2.9% 1/35 • Baseline up to Day 30
General disorders Tinnitus	2.9% 1/35 • Baseline up to Day 30
General disorders Vertigo	8.6% 3/35 • Baseline up to Day 30
General disorders Lacrimation increased	2.9% 1/35 • Baseline up to Day 30
General disorders Dysphonia	2.9% 1/35 • Baseline up to Day 30

Additional Information

Medical Affairs Director

Medical Affairs, Janssen-Cilag (Thailand)

Phone: 662-792-7200

Results disclosure agreements

Principal investigator is a sponsor employee If an Investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication. If requested by the Sponsor, the Investigator will withhold it up to an additional 60 days to allow for filing of a patent application. The Sponsor will not change or suppress the scientific content. For multicenter study, results may not be published before the primary endpoints of a study have been published.
Publication restrictions are in place

Restriction type: OTHER