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

This study has been terminated.
(Product class one recall)
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT00766506
First received: October 3, 2008
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.


Condition Intervention Phase
Pain, Postoperative
Device: Fentanyl IONSYS
Device: Morphine IV PCA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.:

Primary Outcome Measures:
  • Participant's Evaluation of Mean Ability to Mobilize After Surgery [ Time Frame: Hour 72 or early study withdrawal ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Nurse Ease of Care (EOC) Questionnaire Score [ Time Frame: When participant was fit for discharge (FFD) (assessed up to 91 hours) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control [ Time Frame: Hour 72 or early study withdrawal ] [ Designated as safety issue: No ]
    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?"

  • Time to Fit For Discharge (FFD) [ Time Frame: When participant was FFD (assessed up to 91 hours) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Require Rescue Medication [ Time Frame: Baseline up to Hour 3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Require Concomitant Antiemetic Medication [ Time Frame: Baseline up to end of study treatment (Hour 72) ] [ Designated as safety issue: No ]
    Antiemetic medicines are the drugs which prevent vomiting.

  • Number of Participants Who Require Concomitant Non-opioid Analgesics [ Time Frame: Baseline up to end of study treatment (Hour 72) ] [ Designated as safety issue: No ]
    Non-opioid analgesics are non morphine like medications used to get relieve from pain.


Other Outcome Measures:
  • Time to Actual Discharge [ Time Frame: When participant was actually discharged from ward care (assessed up to 258.5 hours) ] [ Designated as safety issue: No ]
    The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.

  • Number of Participants Facing Technical Failure of the Device [ Time Frame: Baseline up to end of study treatment (Hour 72) ] [ Designated as safety issue: Yes ]
    Technical failure was defined as malfunctioning or failure of device to work appropriately.


Enrollment: 108
Study Start Date: May 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl IONSYS
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).
Device: Fentanyl IONSYS
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).
Active Comparator: Morphine IV PCA
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.
Device: Morphine IV PCA
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766506

Locations
United Kingdom
Belfast, United Kingdom
Cardiff, United Kingdom
Edinburgh, United Kingdom
Glasgow, United Kingdom
Liverpool, United Kingdom
Salford, United Kingdom
Solihull, United Kingdom
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00766506     History of Changes
Other Study ID Numbers: CR015211, FENHYDPAI4012, 2008-000529-20
Study First Received: October 3, 2008
Results First Received: January 21, 2013
Last Updated: March 14, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen-Cilag Ltd.:
IONSYS
Fentanyl
Morphine
PCA
Postoperative pain
Mobilization

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Fentanyl
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 29, 2014