Pain, PostoperativePhase 4NCT00766506

An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery

A Phase 4 study testing Fentanyl IONSYS and Morphine IV PCA in people with Pain, Postoperative, run by Janssen-Cilag Ltd. at 7 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Fentanyl IONSYS and Morphine IV PCA
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 7 sitesUnited Kingdom
Study dates: May 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, after an elective major abdominal or orthopedic (pertaining to bones) surgery
Expected to have acute (a quick and severe form of illness in its early stage) moderate (medium level of seriousness) to severe (very serious) post-operative pain requiring parenteral (administration by injection) opioids (morphine like medication) for at least 24 hours after surgery
Participants who have undergone General anesthesia (loss of sensation or feeling), spinal anesthesia of less than or equal to 4 hours duration or epidural (outside the spinal cord) anesthesia
Participants with respiratory rate 10 to 24 breaths per minute
Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS), after titration to comfort with intravenous (IV) morphine Exclusion Criteria
Surgery secondary to malignancy (cancer or other progressively enlarging and spreading tumor) or trauma (injury)

Show all 10Show fewer

History of psychological opioid dependence and/or known or suspected to be opioid dependent
Severe chronic (lasting a long time) obstructive respiratory symptoms susceptibility to respiratory depression, moderate to severe renal (having to do with the kidney) dysfunction
Peri-operative administration of opioids other than morphine, fentanyl, sufentanil, alfentanil or remifentanil
Require high doses of opioids to control their pain (more than 40 milligram morphine IV) during titration to comfort, or more than 6 hours have elapsed since the participant arrived in the recovery room or Monoamine oxidase inhibitors (MAOI) within 14 days pre-study

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United Kingdom7 sites

Study site
Belfast
Study site
Cardiff
Study site
Edinburgh
Study site
Glasgow
Study site
Liverpool
Study site
Salford
Study site
Solihull

Other trials in United Kingdom

About this study

Official title: Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge

Read the detailed description

This is a randomized (study drug assigned by chance), multicentre (when more than one hospital or medical school team work on a medical research study), open-label (participants and physicians are told which treatment the participants are receiving), active-controlled (experimental treatment is compared to a standard treatment), parallel group study (a study comparing the response in two or more groups of participants receiving different treatments). The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. Eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 24 hours after an elective spine or elective orthopedic surgery) will be randomly assigned to receive either Ionsys or morphine IV PCA. Participants' safety will be monitored.

Conditions: Pain, Postoperative
Being tested: Fentanyl IONSYS, Morphine IV PCA
Keywords: IONSYS, Fentanyl, Morphine, PCA, Postoperative pain, Mobilization
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 IONSYSDevice
Participants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).
Morphine IV PCADevice
Morphine sulphate solution will be administered intravenously (IV) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.

Study groups in NCT00766506
Study group	Role	What they receive
Fentanyl IONSYS	Experimental	Participants will receive 40 microgram (mcg) of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS). Receives: Device: Fentanyl IONSYS
Morphine IV PCA	Active comparator	Morphine sulphate solution will be administered intravenously (directly into the vein, IV) by a patient-controlled analgesia (PCA) pump using set bolus (a large amount) doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. Receives: Device: Morphine IV PCA

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant's Evaluation of Mean Ability to Mobilize After Surgery
The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).
Measured: Hour 72 or early study withdrawal

Secondary outcomes (7)

Pain Intensity Numerical Rating Scale (NRS)
Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.
Measured: Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)
Nurse Ease of Care (EOC) Questionnaire Score
Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions.
Measured: When participant was fit for discharge (FFD) (assessed up to 91 hours)
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: "Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?"
Measured: Hour 72 or early study withdrawal
Time to Fit For Discharge (FFD)
Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a "Yes" or "No" basis. When all criteria were answered as Yes, participant was considered to be FFD.
Measured: When participant was FFD (assessed up to 91 hours)
Number of Participants Who Require Rescue Medication
Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.
Measured: Baseline up to Hour 3
Number of Participants Who Require Concomitant Antiemetic Medication
Antiemetic medicines are the drugs which prevent vomiting.
Measured: Baseline up to end of study treatment (Hour 72)
Number of Participants Who Require Concomitant Non-opioid Analgesics
Non-opioid analgesics are non morphine like medications used to get relieve from pain.
Measured: Baseline up to end of study treatment (Hour 72)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Sep 2008

First posted6 Oct 2008 (estimated)
Study startMay 2008
Primary completionSep 2008
Study completionSep 2008

Why it stopped: Product class one recall

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 Pain, PostoperativeStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00766506
Sponsor's protocol ID: CR015211
Other IDs: FENHYDPAI4012, 2008-000529-20, 2008
Status last verified: Mar 2013
First submitted: 3 Oct 2008
Last updated: 25 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge
ClinicalTrials.gov ID: NCT00766506
Acronym / sponsor ID: CR015211
Conditions: Pain, Postoperative
Keywords: IONSYS, Fentanyl, Morphine, PCA, Postoperative pain, Mobilization
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Product class one recall
Enrolment: 108 participants (actual)
Lead sponsor: Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 6 Oct 2008 (estimated)
Results: Posted 25 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fentanyl IONSYS	Experimental	Device: Fentanyl IONSYSParticipants will receive 40 microgram (mcg) of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).
Morphine IV PCA	Active comparator	Device: Morphine IV PCAMorphine sulphate solution will be administered intravenously (directly into the vein, IV) by a patient-controlled analgesia (PCA) pump using set bolus (a large amount) doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants, after an elective major abdominal or orthopedic (pertaining to bones) surgery
Expected to have acute (a quick and severe form of illness in its early stage) moderate (medium level of seriousness) to severe (very serious) post-operative pain requiring parenteral (administration by injection) opioids (morphine like medication) for at least 24 hours after surgery
Participants who have undergone General anesthesia (loss of sensation or feeling), spinal anesthesia of less than or equal to 4 hours duration or epidural (outside the spinal cord) anesthesia
Participants with respiratory rate 10 to 24 breaths per minute
Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS), after titration to comfort with intravenous (IV) morphine Exclusion Criteria

Key exclusion criteria (0 listed)

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 IONSYSParticipants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).	Device	Fentanyl IONSYS
Morphine IV PCAMorphine sulphate solution will be administered intravenously (IV) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.	Device	Morphine IV PCA

Primary outcome

Participant's Evaluation of Mean Ability to Mobilize After Surgery
Time frame: Hour 72 or early study withdrawal
The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).

7 secondary outcomes

Pain Intensity Numerical Rating Scale (NRS)
Time frame: Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)
Nurse Ease of Care (EOC) Questionnaire Score
Time frame: When participant was fit for discharge (FFD) (assessed up to 91 hours)
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Time frame: Hour 72 or early study withdrawal
Time to Fit For Discharge (FFD)
Time frame: When participant was FFD (assessed up to 91 hours)
Number of Participants Who Require Rescue Medication
Time frame: Baseline up to Hour 3
Number of Participants Who Require Concomitant Antiemetic Medication
Time frame: Baseline up to end of study treatment (Hour 72)
Number of Participants Who Require Concomitant Non-opioid Analgesics
Time frame: Baseline up to end of study treatment (Hour 72)

Results and safety

Results posted to the registry on 25 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fentanyl IONSYS	58	53
Morphine IV PCA	50	48

Primary outcome: Participant's Evaluation of Mean Ability to Mobilize After Surgery

Time frame: Hour 72 or early study withdrawal. Mean (Standard Deviation). Unit: Units on scale

Measure	Fentanyl IONSYS n = 58	Morphine IV PCA n = 50
Value	0.02 (0.101)	2.26 (1.146)

Fentanyl IONSYS vs Morphine IV PCA: Least square mean difference: -2.23 (95% CI -2.55 to -1.91), p <0.001, ANCOVA

Population analysed: The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time a signed informed consent form was obtained until the participant was discharged from ward care. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fentanyl IONSYS	1 of 58 (1.7%)	40 of 58 (69%)	Not reported
Morphine IV PCA	2 of 50 (4%)	38 of 50 (76%)	Not reported

Limitations and caveats (from the sponsor): Study was temporarily stopped due to an issue with a batch of drug outside the study and later permanently stopped.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Comparison of Ionsys and routine care with morphine IV PCA in the management of early post-operative mobilisation, ability to mobilise and in time to Fitness For Discharge.Link provided by the sponsor.

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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 Ltd. Clinical Trial study director

Janssen-Cilag Ltd.

7 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 IONSYS and Morphine IV PCA in people with Pain, Postoperative, run by Janssen-Cilag Ltd. at 7 sites in United Kingdom.

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 10 inclusion and 0 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. 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 25 Apr 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?

Participant's Evaluation of Mean Ability to Mobilize After Surgery (time frame: Hour 72 or early study withdrawal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00766506.

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 25 Apr 2013.