Trial Outcomes & Findings for Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery (NCT NCT00779038)
NCT ID: NCT00779038
Last Updated: 2014-05-05
Results Overview
Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
TERMINATED
PHASE4
13 participants
Hour 24
2014-05-05
Participant Flow
Participant milestones
| Measure |
Fentanyl ITS
Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS \[a device which uses an electric current to move drug through the skin into the blood\]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
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|---|---|
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Overall Study
STARTED
|
13
|
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Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Fentanyl ITS
Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS \[a device which uses an electric current to move drug through the skin into the blood\]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
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|---|---|
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Overall Study
Study Prematurely Terminated
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13
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Baseline Characteristics
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
Baseline characteristics by cohort
| Measure |
Fentanyl ITS
n=13 Participants
Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
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7 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
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7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Hour 24Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Hour 48Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of Study treatment (Hour 72)Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hour 72 or early withdrawalPopulation: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hour 72 or early withdrawalPopulation: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hour 72 or early withdrawalPopulation: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Outcome measures
Outcome data not reported
Adverse Events
Fentanyl ITS
Serious adverse events
| Measure |
Fentanyl ITS
n=13 participants at risk
Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
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|---|---|
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Nervous system disorders
Peroneal nerve palsy (severe)
|
7.7%
1/13 • From start of study treatment upto Day 14
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Other adverse events
| Measure |
Fentanyl ITS
n=13 participants at risk
Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site reaction
|
15.4%
2/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site discolouration
|
7.7%
1/13 • Number of events 2 • From start of study treatment upto Day 14
|
|
General disorders
Application site swelling
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site pruritus (left side)
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site pruritus (right side)
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Psychiatric disorders
Euphoric mood
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • From start of study treatment upto Day 14
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Injury, poisoning and procedural complications
Inadequate analgesia
|
15.4%
2/13 • From start of study treatment upto Day 14
|
|
Nervous system disorders
Peroneal nerve palsy (moderate)
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
General disorders
Pyrexia
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Renal and urinary disorders
Urinary retension
|
23.1%
3/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site reaction (left side)
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
General disorders
Application site reaction (right side)
|
7.7%
1/13 • From start of study treatment upto Day 14
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • From start of study treatment upto Day 14
|
Additional Information
Study Responsible Physician
Janssen-Cilag Belgium
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place