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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ClinicalTrials.gov Identifier: NCT01804673 |
Recruitment Status :
Terminated
(The study was prematurely discontinued since study medication was no longer available.)
First Posted : March 5, 2013
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain | Drug: Fentanyl-ITS | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 174 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | March 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Fentanyl-ITS |
Drug: Fentanyl-ITS
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.
Other Name: IONSYS, Fentanyl-ITS |
- Percentage of Participants With Global Assessment of Pain at Hour 24 [ Time Frame: 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.
- Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4 [ Time Frame: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72 ]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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72 ]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 [ Time Frame: Baseline, Hours 24, 48 and 72 ]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 [ Time Frame: Hours 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 [ Time Frame: Hours 24, 48 and 72 ]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 [ Time Frame: Hours 24, 48 and 72 ]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 [ Time Frame: Hours 24, 48 and 72 ]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 [ Time Frame: Hour 72 ]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 [ Time Frame: Hour 72 ]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 [ Time Frame: Hour 72 ]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 [ Time Frame: Hour 72 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804673
Germany | |
Augsburg, Germany | |
Berlin, Germany | |
Bremen, Germany | |
Detmold, Germany | |
Dresden, Germany | |
Erfurt, Germany | |
Erlangen, Germany | |
Frankfurt, Germany | |
Halle, Germany | |
Jena, Germany | |
Kiel, Germany | |
Köln, Germany | |
Leipzig, Germany | |
Lünen, Germany | |
Mainz, Germany | |
Mannheim, Germany | |
Marburg, Germany | |
Münster, Germany | |
Ravensburg, Germany | |
Regensburg, Germany | |
Schwerin, Germany | |
Solingen, Germany |
Study Director: | Janssen-Cilag G.m.b.H, Germany Clinical Trial | Janssen-Cilag G.m.b.H |
Responsible Party: | Janssen-Cilag G.m.b.H |
ClinicalTrials.gov Identifier: | NCT01804673 |
Other Study ID Numbers: |
CR005440 FEN-PAI-3002 2005-004087-24 ( EudraCT Number ) |
First Posted: | March 5, 2013 Key Record Dates |
Results First Posted: | August 5, 2013 |
Last Update Posted: | August 5, 2013 |
Last Verified: | August 2013 |
Postoperative Pain Fentanyl Hydrochloride IONSYS |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |