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

NCT00766506 | Terminated Phase 4 Results

• 3 other identifiers: CR015211FENHYDPAI40122008-000529-20
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 7

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

Conditions

Pain, Postoperative

Keywords

IONSYS; Fentanyl; Morphine; PCA; Postoperative pain; Mobilization

Outcome Measures

Primary Outcomes (1)

• 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).

  Hour 72 or early study withdrawal

Secondary Outcomes (7)

• Pain Intensity Numerical Rating Scale (NRS)

  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

  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

  Hour 72 or early study withdrawal

• Time to Fit For Discharge (FFD)

  When participant was FFD (assessed up to 91 hours)

• Number of Participants Who Require Rescue Medication

  Baseline up to Hour 3

Other Outcomes (2)

• Time to Actual Discharge

  When participant was actually discharged from ward care (assessed up to 258.5 hours)

• Number of Participants Facing Technical Failure of the Device

  Baseline up to end of study treatment (Hour 72)

Study Arms (2)

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).

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.

Device: Morphine IV PCA

Interventions

Fentanyl IONSYS DEVICE

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).

Fentanyl IONSYS

Morphine IV PCA DEVICE

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.

Morphine IV PCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (7)

Unknown Facility

Belfast, United Kingdom

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Salford, United Kingdom

Location

Unknown Facility

Solihull, United Kingdom

Location

Related Links

• 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Study was temporarily stopped due to an issue with a batch of drug outside the study and later permanently stopped.

Results Point of Contact

• Title: Study Responsible Physician
• Organization: Janssen-Cilag Ltd. 50-100 Holmers Farm Way, High Wycombe , BUCKS, UK, HP12 4EG

+44 (0) 1494 567 444

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 25, 2013
• Results First Posted: April 25, 2013

Record last verified: 2013-03

Locations

GB (7)