Trial Outcomes & Findings for An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain (NCT NCT01774903)

NCT ID: NCT01774903

Last Updated: 2013-03-25

Results Overview

Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 45 participants
• Primary outcome timeframe: Day 15
• Results posted on: 2013-03-25

Participant Flow

Participant milestones

Measure	Transdermal Therapeutic System (TTS)-Fentanyl TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study STARTED	45
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Transdermal Therapeutic System (TTS)-Fentanyl TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	2
Overall Study Lack of Efficacy	1
Overall Study Ineligible to continue the trial	1

Baseline Characteristics

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain

Baseline characteristics by cohort

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=45 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Age Continuous	55.80 years STANDARD_DEVIATION 11.53 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Pain Intensity Score by Visual Analog Scale (VAS)	6.57 centimeter (cm) STANDARD_DEVIATION 1.44 • 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 one post baseline efficacy assessment.

Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=37 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Pain Intensity at Day 15	4.85 cm Standard Deviation 2.13

PRIMARY outcome

Timeframe: Day 30

Population: ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.

Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=37 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Pain Intensity at Day 30	4.89 cm Standard Deviation 2.46

SECONDARY outcome

Timeframe: Day 30

Population: Per protocol (PP) population included all participants who completed the 30-day study.

Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=34 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Number of Participants With Investigator Global Assessment Efficacy, 100 percent worse	0 participants
Number of Participants With Investigator Global Assessment Efficacy, 75 percent worse	1 participants
Number of Participants With Investigator Global Assessment Efficacy, 50 percent worse	2 participants
Number of Participants With Investigator Global Assessment Efficacy, 25 percent worse	1 participants
Number of Participants With Investigator Global Assessment Efficacy, unchanged	6 participants
Number of Participants With Investigator Global Assessment Efficacy, 25 percent improvement	6 participants
Number of Participants With Investigator Global Assessment Efficacy, 50 percent improvement	11 participants
Number of Participants With Investigator Global Assessment Efficacy, 75 percent improvement	6 participants
Number of Participants With Investigator Global Assessment Efficacy, 100 percent improvement	1 participants
Number of Participants With Investigator Global Assessment Safety, no	17 participants
Number of Participants With Investigator Global Assessment Safety, mild	15 participants
Number of Participants With Investigator Global Assessment Safety, moderate	1 participants
Number of Participants With Investigator Global Assessment Safety, severe	1 participants
Number of Participants With Investigator Global Assessment Safety, most severe	0 participants
Number of Participants With Investigator Global Assessment Overall satisfaction, no	6 participants
Number of Participants With Investigator Global Assessment Overall satisfaction, mild	8 participants
Number of Participants With Investigator Global Assessment Overall satisfaction, moderate	11 participants
Number of Participants With Investigator Global Assessment Overall satisfaction, good	7 participants
Number of Participants With Investigator Global Assessment Overall satisfaction, excellent	2 participants

SECONDARY outcome

Timeframe: Day 30

Population: PP population included all participants who completed the 30-day study.

Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=34 Participants TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Number of Participants With Participant Global Assessment Efficacy, 75 percent worse	0 participants
Number of Participants With Participant Global Assessment Efficacy, 50 percent worse	2 participants
Number of Participants With Participant Global Assessment Efficacy, 25 percent worse	1 participants
Number of Participants With Participant Global Assessment Efficacy, unchanged	4 participants
Number of Participants With Participant Global Assessment Efficacy, 25 percent improvement	13 participants
Number of Participants With Participant Global Assessment Efficacy, 50 percent improvement	11 participants
Number of Participants With Participant Global Assessment Efficacy, 75 percent improvement	1 participants
Number of Participants With Participant Global Assessment Efficacy, 100 percent improvement	1 participants
Number of Participants With Participant Global Assessment Safety, no	12 participants
Number of Participants With Participant Global Assessment Safety, mild	15 participants
Number of Participants With Participant Global Assessment Safety, moderate	6 participants
Number of Participants With Participant Global Assessment Safety, severe	0 participants
Number of Participants With Participant Global Assessment Safety, most severe	1 participants
Number of Participants With Participant Global Assessment Overall satisfaction, no	3 participants
Number of Participants With Participant Global Assessment Overall satisfaction, mild	10 participants
Number of Participants With Participant Global Assessment Overall satisfaction, moderate	15 participants
Number of Participants With Participant Global Assessment Overall satisfaction, good	5 participants
Number of Participants With Participant Global Assessment Overall satisfaction, excellent	1 participants
Number of Participants With Participant Global Assessment Efficacy, 100 percent worse	1 participants

Adverse Events

Transdermal Therapeutic System (TTS)-Fentanyl

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=45 participants at risk TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Gastrointestinal disorders Nausea	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study
Gastrointestinal disorders Vomiting	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study
Nervous system disorders Vertigo	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study

Other adverse events

Measure	Transdermal Therapeutic System (TTS)-Fentanyl n=45 participants at risk TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
Gastrointestinal disorders Vomiting	33.3% 15/45 • From signing of informed consent until 30 days after the participant has completed the study
Gastrointestinal disorders Nausea	22.2% 10/45 • From signing of informed consent until 30 days after the participant has completed the study
Gastrointestinal disorders Constipation	15.6% 7/45 • From signing of informed consent until 30 days after the participant has completed the study
Gastrointestinal disorders Diarrhoea	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study
Nervous system disorders Dizziness	37.8% 17/45 • From signing of informed consent until 30 days after the participant has completed the study
Nervous system disorders Bitter taste	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study
Nervous system disorders Drowsiness	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study
Skin and subcutaneous tissue disorders Itching	6.7% 3/45 • From signing of informed consent until 30 days after the participant has completed the study
Skin and subcutaneous tissue disorders Rash	4.4% 2/45 • From signing of informed consent until 30 days after the participant has completed the study
Metabolism and nutrition disorders Loss of appetizer	4.4% 2/45 • From signing of informed consent until 30 days after the participant has completed the study
Cardiac disorders Palpitation	4.4% 2/45 • From signing of informed consent until 30 days after the participant has completed the study
Skin and subcutaneous tissue disorders Irritate	2.2% 1/45 • From signing of informed consent until 30 days after the participant has completed the study

Additional Information

Medical Affairs Director

Medical Affairs, Janssen-Cilag (Thailand)

Phone: 662-792-7200

Results disclosure agreements

• Principal investigator is a sponsor employee Company has the right to publish the data which generated here under by Principal Investigator (PI), without PIs approval. The PI has the right to publish the results, but prior to submission, PI will provide at least 60 days to company for review. No paper that incorporates Company Confidential Information will be submitted for publication without Company prior written consent. If requested, the PI will withhold such publication for up to an additional 60 days to allow for filing of a patent.
• Publication restrictions are in place

Restriction type: OTHER