Back to resultsA Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Fentanyl-ITS
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain, Fentanyl Hydrochloride, IONSYS
Eligibility Criteria
Inclusion Criteria:
- Participants with American Society of Anesthesiology (specialty concerned with the study of anesthetics [drug that is used to produce loss of pain sensation] and anesthesia [loss of sensation or feeling]) pre-operative physical status 1, 2 or 3
- Participants who are expected to remain hospitalized for at least 24 hours post-operatively (after the surgery)
- Participants, after an elective major surgical procedure (surgery which could be postponed or not done at all without danger to the participant), who are expected to have moderate or severe pain requiring parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours after surgery
- Participants who are capable of understanding and cooperating with the requirements of the study and operating a transdermal (through the skin) Patients-Controlled Analgesia (PCA; methods of pain relief that may be used with or in place of analgesics [drug used to control pain])
- Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest imaginable pain at movement of the operated limb or body region, after titration (slow increase in drug dosage, guided by participant's responses) to comfort according to current postoperative procedures
Exclusion Criteria:
- Participants allergic or hypersensitive (very sensitive) to fentanyl or cetylpyridinium chloride or to skin adhesives
- Participants who are known or suspected to be strong opioid dependent, or who have a very high a need for strong opioids before entering the study
- Participants with a history of psychological opioid dependence before the start of the study
- Participants who are known or suspected to have abused any drug substance or alcohol in the opinion of the investigator
- Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs of the last dose of study drug.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fentanyl-ITS
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Global Assessment of Pain at Hour 24
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.
Secondary Outcome Measures
Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4
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.
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
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).
Time Spent Out of the Bed Per Day by the Participant
Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.
Time to Mobilization
Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
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.
Percentage of Participants With Physician Global Assessment of Pain
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.
Percentage of Participants With Nursing Staff Global Assessment of Pain
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.
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
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.
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
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.
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
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.
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
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.
Post-Operative Phase (PPP33) Quality of Life Questionnaire Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804673
Brief Title
A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
Official Title
Global Assessment of Treatment With IONSYS and Its Handling by Patients, Doctors and Nursing Staff in the Management of Acute Moderate to Severe Post-Surgery Pain in Hospitalised Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely discontinued since study medication was no longer available.
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag G.m.b.H
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.
Detailed Description
This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative participants' who have undergone elective surgery (surgery which could be postponed or not done at all without danger to the participant). The study will consists of 2 phases: screening phase (which comprises of pre-operative and post-operative stages) and an open label treatment phase. The participants will be treated with 40 microgram (mcg) of fentanyl transdermally per on-demand dose; each delivered over 10 minutes for a maximum of 6 doses (240 mcg) per hour for 24 hours and a maximum of 80 doses (3.2 milligram [mg]). Each system will inactivate at 80 doses or 24 hour, whichever occurs first. A new system will be applied every 24 hours unless the participant has used 80 doses in less than 24 hours. Maximum treatment duration of 72 hours is allowed. Participants will be expected to require parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours post-operatively. This study will evaluate participant's, nurse's and physician's assessment of fentanyl-ITS under routine conditions. Participants' safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative Pain, Fentanyl Hydrochloride, IONSYS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl-ITS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fentanyl-ITS
Other Intervention Name(s)
IONSYS, Fentanyl-ITS
Intervention Description
Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release 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 will be 72 hours.
Primary Outcome Measure Information:
Title
Percentage of Participants With Global Assessment of Pain at Hour 24
Description
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.
Time Frame
Hour 24
Secondary Outcome Measure Information:
Title
Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4
Description
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.
Time Frame
Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72
Title
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Description
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).
Time Frame
Baseline, Hour 24, 48 and 72
Title
Time Spent Out of the Bed Per Day by the Participant
Description
Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.
Time Frame
Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72
Title
Time to Mobilization
Description
Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.
Time Frame
Baseline, Hours 24, 48 and 72
Title
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Description
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.
Time Frame
Hours 48 and 72
Title
Percentage of Participants With Physician Global Assessment of Pain
Description
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.
Time Frame
Hours 24, 48 and 72
Title
Percentage of Participants With Nursing Staff Global Assessment of Pain
Description
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.
Time Frame
Hours 24, 48 and 72
Title
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Description
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.
Time Frame
Hours 24, 48 and 72
Title
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Description
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.
Time Frame
Hour 72
Title
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
Description
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.
Time Frame
Hour 72
Title
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Description
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.
Time Frame
Hour 72
Title
Post-Operative Phase (PPP33) Quality of Life Questionnaire Score
Description
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.
Time Frame
Hour 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with American Society of Anesthesiology (specialty concerned with the study of anesthetics [drug that is used to produce loss of pain sensation] and anesthesia [loss of sensation or feeling]) pre-operative physical status 1, 2 or 3
Participants who are expected to remain hospitalized for at least 24 hours post-operatively (after the surgery)
Participants, after an elective major surgical procedure (surgery which could be postponed or not done at all without danger to the participant), who are expected to have moderate or severe pain requiring parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours after surgery
Participants who are capable of understanding and cooperating with the requirements of the study and operating a transdermal (through the skin) Patients-Controlled Analgesia (PCA; methods of pain relief that may be used with or in place of analgesics [drug used to control pain])
Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest imaginable pain at movement of the operated limb or body region, after titration (slow increase in drug dosage, guided by participant's responses) to comfort according to current postoperative procedures
Exclusion Criteria:
Participants allergic or hypersensitive (very sensitive) to fentanyl or cetylpyridinium chloride or to skin adhesives
Participants who are known or suspected to be strong opioid dependent, or who have a very high a need for strong opioids before entering the study
Participants with a history of psychological opioid dependence before the start of the study
Participants who are known or suspected to have abused any drug substance or alcohol in the opinion of the investigator
Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs of the last dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag G.m.b.H, Germany Clinical Trial
Organizational Affiliation
Janssen-Cilag G.m.b.H
Official's Role
Study Director
Facility Information:
City
Augsburg
Country
Germany
City
Berlin
Country
Germany
City
Bremen
Country
Germany
City
Detmold
Country
Germany
City
Dresden
Country
Germany
City
Erfurt
Country
Germany
City
Erlangen
Country
Germany
City
Frankfurt
Country
Germany
City
Halle
Country
Germany
City
Jena
Country
Germany
City
Kiel
Country
Germany
City
Köln
Country
Germany
City
Leipzig
Country
Germany
City
Lünen
Country
Germany
City
Mainz
Country
Germany
City
Mannheim
Country
Germany
City
Marburg
Country
Germany
City
Münster
Country
Germany
City
Ravensburg
Country
Germany
City
Regensburg
Country
Germany
City
Schwerin
Country
Germany
City
Solingen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
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