Postoperative PainPhase 4NCT01804673
A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
A Phase 4 study testing Fentanyl-ITS in people with Postoperative Pain, run by Janssen-Cilag G.m.b.H at 22 sites in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl-ITS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 22 sitesGermany
- Study dates
- Mar 2008to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Study site
Augsburg
Study site
Berlin
Study site
Bremen
Study site
Cologne
Study site
Detmold
Study site
Dresden
Study site
Erfurt
Study site
Erlangen
Study site
Frankfurt
Study site
Halle
Study site
Jena
Study site
Kiel
Study site
Leipzig
Study site
Lünen
Study site
Mainz
Study site
Mannheim
Study site
Marburg
Study site
Münster
Study site
Ravensburg
Study site
Regensburg
Study site
Schwerin
Study site
Solingen
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl-ITS
- Keywords
- Postoperative Pain, Fentanyl Hydrochloride, IONSYS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl-ITSDrug
Also called IONSYS, 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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl-ITS | Experimental | Not described Receives: Drug: Fentanyl-ITS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hour 24
Secondary outcomes (12)
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.
Measured: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72
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).
Measured: Baseline, Hour 24, 48 and 72
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.
Measured: Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72
Time to Mobilization
Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.
Measured: Baseline, Hours 24, 48 and 72
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.
Measured: Hours 48 and 72
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.
Measured: Hours 24, 48 and 72
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.
Measured: Hours 24, 48 and 72
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.
Measured: Hours 24, 48 and 72
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.
Measured: Hour 72
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.
Measured: Hour 72
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.
Measured: Hour 72
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.
Measured: Hour 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: The study was prematurely discontinued since study medication was no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag G.m.b.H
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag G.m.b.H, Germany Clinical Trial, Study director, Janssen-Cilag G.m.b.H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804673
- Sponsor's protocol ID
- CR005440
- Other IDs
- FEN-PAI-3002, 2005-004087-24, 2005
- Status last verified
- Aug 2013
- First submitted
- 4 Mar 2013
- Last updated
- 5 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01804673
- Acronym / sponsor ID
- CR005440
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Fentanyl Hydrochloride, IONSYS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued since study medication was no longer available.
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Janssen-Cilag G.m.b.HIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Posted 5 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl-ITS | Experimental | Drug: Fentanyl-ITS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl-ITSAlso: IONSYS, Fentanyl-ITSFentanyl 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. | Drug | Fentanyl-ITS |
Primary outcome
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.
12 secondary outcomes
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
Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72
Time frame: Baseline, Hour 24, 48 and 72
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
Time to Mobilization
Time frame: Baseline, Hours 24, 48 and 72
Percentage of Participants With Global Assessment of Pain at Hour 48 and 72
Time frame: Hours 48 and 72
Percentage of Participants With Physician Global Assessment of Pain
Time frame: Hours 24, 48 and 72
Percentage of Participants With Nursing Staff Global Assessment of Pain
Time frame: Hours 24, 48 and 72
Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization
Time frame: Hours 24, 48 and 72
Comprehensibility of the Information Material (IM): Physician Questionnaire Responses
Time frame: Hour 72
Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses
Time frame: Hour 72
Comprehensibility of the Information Material (IM): Participant Questionnaire Responses
Time frame: Hour 72
Post-Operative Phase (PPP33) Quality of Life Questionnaire Score
Time frame: Hour 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag G.m.b.H, Germany Clinical Trial study director
Janssen-Cilag G.m.b.H
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl-ITS in people with Postoperative Pain, run by Janssen-Cilag G.m.b.H at 22 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Global Assessment of Pain at Hour 24 (time frame: Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.