Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain (NCT NCT01804673)
NCT ID: NCT01804673
Last Updated: 2013-08-05
Results Overview
Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
174 participants
Primary outcome timeframe
Hour 24
Results posted on
2013-08-05
Participant Flow
Participant milestones
| Measure |
Fentanyl
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Overall Study
STARTED
|
174
|
|
Overall Study
Completed Hour 24
|
170
|
|
Overall Study
Completed Hour 48
|
79
|
|
Overall Study
Completed Hour 72
|
36
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
140
|
Reasons for withdrawal
| Measure |
Fentanyl
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Change to Oral Therapy
|
37
|
|
Overall Study
No Further Therapy Required
|
84
|
|
Overall Study
Use of Prohibited Medication
|
1
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
Baseline characteristics by cohort
| Measure |
Fentanyl
n=174 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Age Continuous
|
49.3 Years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 24Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.
Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Percentage of Participants With Global Assessment of Pain at Hour 24
Response
|
82.9 percent of participants
Interval 76.4 to 88.3
|
|
Percentage of Participants With Global Assessment of Pain at Hour 24
No response
|
17.1 percent of participants
Interval 11.7 to 23.6
|
SECONDARY outcome
Timeframe: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.
Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.
Outcome measures
| Measure |
Fentanyl
n=125 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4
Baseline to Hour 24 (n=125)
|
21.3 hours
Standard Deviation 4.3
|
|
Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4
Hour 24 to Hour 48 (n= 57)
|
22.2 hours
Standard Deviation 4.1
|
|
Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4
Hour 48 to Hour 72 (n= 23)
|
22.7 hours
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, Hour 24, 48 and 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.
Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).
Outcome measures
| Measure |
Fentanyl
n=168 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Baseline (n= 168)
|
3.0 units on scale
Standard Deviation 1.2
|
|
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Change at Hour 24 (n= 157)
|
-0.9 units on scale
Standard Deviation 1.7
|
|
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Change at Hour 48 (n= 73)
|
-1.2 units on scale
Standard Deviation 1.8
|
|
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Change at Hour 72 (n= 31)
|
-1.3 units on scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.
Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.
Outcome measures
| Measure |
Fentanyl
n=126 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Time Spent Out of the Bed Per Day by the Participant
Baseline to Hour 24 (n= 126)
|
38.1 minutes
Standard Deviation 94.5
|
|
Time Spent Out of the Bed Per Day by the Participant
Hour 24 to Hour 48 (n= 50)
|
87.5 minutes
Standard Deviation 121.6
|
|
Time Spent Out of the Bed Per Day by the Participant
Hour 48 to Hour 72 (n= 26)
|
146.7 minutes
Standard Deviation 193.9
|
SECONDARY outcome
Timeframe: Baseline, Hours 24, 48 and 72Population: Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.
Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hours 48 and 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for this measure at specified time point.
Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
Outcome measures
| Measure |
Fentanyl
n=79 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Hour 48; Response (n= 79)
|
86.1 percent of participants
Interval 76.5 to 92.8
|
|
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Hour 48; No response (n= 79)
|
12.7 percent of participants
Interval 6.2 to 22.0
|
|
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Hour 48; Missing (n= 79)
|
1.3 percent of participants
Confidence Interval was not calculated for missing participants.
|
|
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Hour 72; Response (n= 36)
|
97.2 percent of participants
Interval 85.5 to 99.9
|
|
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Hour 72; No response (n= 36)
|
2.8 percent of participants
Interval 0.1 to 14.5
|
SECONDARY outcome
Timeframe: Hours 24, 48 and 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies those participants evaluable for this measure at the specified time point.
Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 24; Response (n= 170)
|
88.2 percent of participants
Interval 82.4 to 92.7
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 24; No response (n= 170)
|
11.2 percent of participants
Interval 6.9 to 16.9
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 24; Missing (n= 170)
|
0.6 percent of participants
Confidence Interval was not calculated for missing participants.
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 48; Response (n= 79)
|
88.6 percent of participants
Interval 79.5 to 94.7
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 48; No response (n= 79)
|
11.4 percent of participants
Interval 5.3 to 20.5
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 72; Response (n= 36)
|
97.2 percent of participants
Interval 85.5 to 99.9
|
|
Percentage of Participants With Physician Global Assessment of Pain
Hour 72; No response (n= 36)
|
2.8 percent of participants
Interval 0.1 to 14.5
|
SECONDARY outcome
Timeframe: Hours 24, 48 and 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies those participants evaluable for this measure at the specified time point.
Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 72; Missing (n= 36)
|
2.8 percent of participants
Confidence Interval was not calculated for missing participants.
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 24; Response (n= 170)
|
87.1 percent of participants
Interval 81.1 to 91.7
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 24; No response (n= 170)
|
12.4 percent of participants
Interval 7.8 to 18.3
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 24; Missing (n= 170)
|
0.6 percent of participants
Confidence Interval was not calculated for missing participants.
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 48; Response (n= 79)
|
88.6 percent of participants
Interval 79.5 to 94.7
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 48; No response (n= 79)
|
11.4 percent of participants
Interval 5.3 to 20.5
|
|
Percentage of Participants With Nursing Staff Global Assessment of Pain
Hour 72; Response (n= 36)
|
97.2 percent of participants
Interval 85.5 to 99.9
|
SECONDARY outcome
Timeframe: Hours 24, 48 and 72Population: Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'n' signifies participants evaluable at specified time point for specified item.
Physicians were asked to rate the participant's ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, 'Partial' indicates that mobilization of participant was moderately limited due to pain.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question C; Partial (n=36)
|
30.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question C; Missing (n=36)
|
11.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question D; Yes (n=36)
|
86.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question A; Missing (n=36)
|
11.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question D; No (n=36)
|
2.8 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question D; Missing (n=36)
|
11.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question A; Yes (n=36)
|
41.7 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question A; No (n=36)
|
47.2 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question B; Yes (n=36)
|
58.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question B; No (n=36)
|
30.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question B; Missing (n=36)
|
11.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question C; Yes (n=36)
|
61.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question C; No (n=36)
|
27.8 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 2-Question C; Missing (n=36)
|
11.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question C; Yes (n=36)
|
5.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question A; Missing (n=36)
|
8.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question B; Yes (n=170)
|
54.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question B; No (n=170)
|
44.7 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question A; Yes (n=170)
|
95.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question A; No (n=170)
|
4.7 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question C; Yes (n=170)
|
16.5 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question C; No (n=170)
|
39.4 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question C; Partial (n=170)
|
43.5 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question C; Missing (n=170)
|
0.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question D; Yes (n=170)
|
91.8 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 1-Question D; No (n=170)
|
8.2 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question A; Yes (n=170)
|
30.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question A; No (n=170)
|
62.4 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question A; Missing (n=170)
|
7.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question B; Missing (n=170)
|
1.2 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question C; Yes (n=170)
|
58.8 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 24 Part 2-Question C; No (n=170)
|
41.2 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question A; Yes (n=79)
|
92.4 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question A; No (n=79)
|
2.5 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question A; Missing (n=79)
|
5.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question C; Yes (n=79)
|
8.9 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question C; No (n=79)
|
51.9 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question C; Partial (n=79)
|
32.9 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question C; Missing (n=79)
|
6.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question D; Yes (n=79)
|
88.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question D; No (n=79)
|
6.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 1-Question D; Missing (n=79)
|
5.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question A; Yes (n=79)
|
40.5 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question A; No (n=79)
|
53.2 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question A; Missing (n=79)
|
6.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question B; Yes (n=79)
|
68.4 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question B; No (n=79)
|
25.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question B; Missing (n=79)
|
6.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question C; Yes (n=79)
|
63.3 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question C; No (n=79)
|
31.6 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 48 Part 2-Question C; Missing (n=79)
|
5.1 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question A; Yes (n=36)
|
91.7 percent of participants
|
|
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Hour 72 Part 1-Question C; No (n=36)
|
52.8 percent of participants
|
SECONDARY outcome
Timeframe: Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.
Outcome measures
| Measure |
Fentanyl
n=36 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question D; Yes
|
83.3 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question D; No
|
5.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question D; Missing
|
11.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question E; Yes
|
77.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question E; No
|
11.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 2-Question E; Missing
|
11.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 3-Question A; Yes
|
88.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 3-Question A; Missing
|
11.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 3-Question B; Yes
|
88.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Part 3-Question B; Missing
|
11.1 percent of participants
|
SECONDARY outcome
Timeframe: Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.
Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IM-Question A; Yes
|
97.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IM-Question A; Missing
|
2.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IM-Question B; Yes
|
95.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IM-Question B; No
|
1.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IM-Question B; Missing
|
2.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question A; Yes
|
95.3 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question A; No
|
1.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question A; Missing
|
2.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question B; Yes
|
23.5 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question B; No
|
73.5 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question B; Missing
|
2.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question C; Yes
|
90.0 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question C; No
|
5.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question C; Missing
|
4.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IV PCA-Question; Yes
|
84.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IV PCA-Question; No
|
10.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IV PCA-Question; Missing
|
5.3 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question D; Yes
|
31.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question D; No
|
48.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question D; Missing
|
20.0 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question E; Yes
|
52.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question E; No
|
32.4 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question E; Missing
|
14.7 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question F; Yes
|
47.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question F; No
|
37.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question F; Missing
|
14.7 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question G; Yes
|
71.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question G; No
|
12.4 percent of participants
|
|
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
IONSYS PCA-Question G; Missing
|
15.9 percent of participants
|
SECONDARY outcome
Timeframe: Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.
Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system's beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.
Outcome measures
| Measure |
Fentanyl
n=170 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question A; Yes
|
77.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question A; No
|
1.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question A; Missing
|
21.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question B; Yes
|
77.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question B; No
|
1.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question B; Missing
|
21.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question C; Yes
|
78.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question C; Missing
|
21.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question D; Yes
|
77.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question D; No
|
1.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question D; Missing
|
21.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question E; Yes
|
72.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question E; No
|
4.7 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question E; Missing
|
22.4 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question F; Yes
|
75.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question F; No
|
1.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
QuestionF; Missing
|
22.4 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question G; Yes
|
75.9 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question G; No
|
0.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question G; Missing
|
23.5 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question H; Yes
|
30.0 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question H; No
|
46.5 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question H; Missing
|
23.5 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question I; Yes
|
60.6 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question I; No
|
17.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question I; Missing
|
22.4 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question J; Yes
|
4.1 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question J; No
|
71.2 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question J; Missing
|
24.7 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question K; Yes
|
75.3 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question K; No
|
1.8 percent of participants
|
|
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Question K; Missing
|
22.9 percent of participants
|
SECONDARY outcome
Timeframe: Hour 72Population: Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.
Outcome measures
| Measure |
Fentanyl
n=105 Participants
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Post-Operative Phase (PPP33) Quality of Life Questionnaire Score
|
76.8 units on scale
Standard Deviation 9.4
|
Adverse Events
Fentanyl
Serious events: 3 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl
n=174 participants at risk
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.57%
1/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.57%
1/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Impaired healing
|
0.57%
1/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
Other adverse events
| Measure |
Fentanyl
n=174 participants at risk
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
15.5%
27/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
16/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
3/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site erythema
|
10.3%
18/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site vesicles
|
2.9%
5/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site burn
|
2.3%
4/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site irritation
|
1.7%
3/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site pruritus
|
1.7%
3/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site oedema
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
General disorders
Application site pain
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Nervous system disorders
Dizziness
|
3.4%
6/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Vascular disorders
Hypotension
|
3.4%
6/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.3%
4/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
2.3%
4/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
5/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
3/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Investigations
Oxygen saturation decreased
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
2/174 • From signing of informed consent until Day 7 after end of treatment
Treatment-emergent are events between first dose of study drug and up to 7 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
Additional Information
Head
Clinic for Anaesthesiology, Intensive Care Unit and Pain Therapy at the Westfälische Wilhelms-Universität Münster, Albert-Schweitzer-Str. 33, 48149 Munster.
Phone: +49 251 / 83 - 4 72 52
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place