Trial Outcomes & Findings for An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain (NCT NCT01816243)
NCT ID: NCT01816243
Last Updated: 2014-04-28
Results Overview
Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
Baseline and Day 15
Results posted on
2014-04-28
Participant Flow
Participant milestones
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
|
|---|---|
|
Overall Study
STARTED
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39
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Not eligible for the study
|
1
|
|
Overall Study
Amputation
|
3
|
Baseline Characteristics
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain
Baseline characteristics by cohort
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=38 Participants
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
|
|---|---|
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Age, Continuous
|
50.39 Years
STANDARD_DEVIATION 16.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
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Pain Intensity Rating
|
6.54 units on a scale
STANDARD_DEVIATION 2.02 • n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and Day 15Population: Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.
Outcome measures
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=37 Participants
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
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Change From Baseline in Pain Intensity Rating at Day 15
|
-1.56 Units on a scale
Standard Deviation 3.15
|
PRIMARY outcome
Timeframe: Baseline and Day 30Population: The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.
Outcome measures
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=37 Participants
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
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Change From Baseline in Pain Intensity Rating at Day 30
|
-1.95 Units on a scale
Standard Deviation 3.28
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SECONDARY outcome
Timeframe: Day 30Population: The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Investigator would complete 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% 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). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported.
Outcome measures
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=27 Participants
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
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Number of Participants With Investigator's Global Assessment
Efficacy, 100% Worse
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 75% Worse
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 50% Worse
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 25% Worse
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, Unchanged
|
7 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 25% Improve
|
2 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 50% Improve
|
6 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 75% Improve
|
4 Participants
|
|
Number of Participants With Investigator's Global Assessment
Efficacy, 100% Improve
|
7 Participants
|
|
Number of Participants With Investigator's Global Assessment
Safety, No
|
16 Participants
|
|
Number of Participants With Investigator's Global Assessment
Safety, Mild
|
9 Participants
|
|
Number of Participants With Investigator's Global Assessment
Safety, Moderate
|
2 Participants
|
|
Number of Participants With Investigator's Global Assessment
Safety, Severe
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment
Safety, Most severe
|
0 Participants
|
|
Number of Participants With Investigator's Global Assessment
Overall Satisfaction, No
|
1 Participants
|
|
Number of Participants With Investigator's Global Assessment
Overall Satisfaction, Mild
|
7 Participants
|
|
Number of Participants With Investigator's Global Assessment
Overall Satisfaction, Moderate
|
6 Participants
|
|
Number of Participants With Investigator's Global Assessment
Overall Satisfaction, Severe
|
8 Participants
|
|
Number of Participants With Investigator's Global Assessment
Overall Satisfaction, Most Severe
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 30Population: The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points.
Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% 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). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported.
Outcome measures
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=34 Participants
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
|
Number of Participants With Participant's Global Assessment
Efficacy, 100% Worse (n=34)
|
1 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 75% Worse (n=34)
|
0 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 50% Worse (n=34)
|
2 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 25% Worse (n=34)
|
1 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, Unchanged (n=34)
|
4 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 25% Improve (n=34)
|
13 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 50% Improve (n=34)
|
11 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 75% Improve (n=34)
|
1 Participants
|
|
Number of Participants With Participant's Global Assessment
Efficacy, 100% Improve (n=34)
|
1 Participants
|
|
Number of Participants With Participant's Global Assessment
Safety, No (n=27)
|
16 Participants
|
|
Number of Participants With Participant's Global Assessment
Safety, Mild (n=27)
|
9 Participants
|
|
Number of Participants With Participant's Global Assessment
Safety, Moderate (n=27)
|
2 Participants
|
|
Number of Participants With Participant's Global Assessment
Safety, Severe (n=27)
|
0 Participants
|
|
Number of Participants With Participant's Global Assessment
Safety, Most severe (n=27)
|
0 Participants
|
|
Number of Participants With Participant's Global Assessment
Overall Satisfaction, No (n=27)
|
1 Participants
|
|
Number of Participants With Participant's Global Assessment
Overall Satisfaction, Mild (n=27)
|
7 Participants
|
|
Number of Participants With Participant's Global Assessment
Overall Satisfaction, Moderate (n=27)
|
6 Participants
|
|
Number of Participants With Participant's Global Assessment
Overall Satisfaction, Severe (n=27)
|
8 Participants
|
|
Number of Participants With Participant's Global Assessment
Overall Satisfaction, Most Severe (n=27)
|
5 Participants
|
Adverse Events
Transdermal Therapeutic System (TTS) - Fentanyl
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=39 participants at risk
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
|
|---|---|
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Infections and infestations
Septic shock
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
Other adverse events
| Measure |
Transdermal Therapeutic System (TTS) - Fentanyl
n=39 participants at risk
Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
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|---|---|
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General disorders
Flu-like symptom
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2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Cardiac disorders
Palpitation
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2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Dizziness
|
7.7%
3/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Drowsiness
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15.4%
6/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Dullness
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2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Insomnia
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Nightmare
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Cardiac disorders
Hypotension
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Nervous system disorders
Peripheral neuropathy
|
5.1%
2/39 • From first dose of study medication up to Day 30
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • From first dose of study medication up to Day 30
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
2/39 • From first dose of study medication up to Day 30
|
|
Gastrointestinal disorders
Nausea
|
17.9%
7/39 • From first dose of study medication up to Day 30
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • From first dose of study medication up to Day 30
|
|
Skin and subcutaneous tissue disorders
Angular ulcer
|
2.6%
1/39 • From first dose of study medication up to Day 30
|
|
Skin and subcutaneous tissue disorders
Itching
|
20.5%
8/39 • From first dose of study medication up to Day 30
|
|
Skin and subcutaneous tissue disorders
Non pitting edema
|
10.3%
4/39 • From first dose of study medication up to Day 30
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
4/39 • From first dose of study medication 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 Timing and publication of the results will be subject to mutual agreement in the project between all Investigators participating in the project and Janssen-Cilag., Thailand. All manuscripts and abstracts utilizing the data from this study are subjected to the approval of Janssen. All manuscripts and abstract must be sent to Janssen at least one month prior to the submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER