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Ionsys Mobilisation: Patient Analgesia Control Trial (IMPACT)
This study has been terminated.
( Following the recall of Ionsys, the study has been stopped. Data analysis will be undertaken in accordance with the Analysis Plan. )

First Received on October 3, 2008.   Last Updated on May 18, 2011   History of Changes
Sponsor: Janssen-Cilag Ltd.
Information provided by: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00766506
  Purpose

The purpose of this study is to evaluate the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) which delivers 40 mcg Fentanyl per on demand dose and morphine Intravenous (IV) PCA for management of acute moderate to severe post-operative pain in patients who have undergone elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty). Morphine IV PCA will be prescriber as per routine practice, up to a maximum total of 20mg morphine per 2 hours.


Condition Intervention Phase
Pain, Postoperative
Hysterectomy
Arthroplasty, Replacement, Hip
Mobility
Drug: Morphine IV PCA
Drug: Ionsys
Phase IV

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:
  • Patient's evaluation of their ability to mobilise post-operatively. Assessed hourly during the first 6 hours. If the patient is still receiving study treatment, assessments will be made at hours 8, 12, 24, 48, 72 hours & when deem Fit For Discharge [ Time Frame: The primary efficacy endpoint is the patient's ability to mobilise assessed using three validated questions assessed at time of study treatment discontinuation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's Pain Rating, Nurse Ease of Care, Patient Global Assessment of Method of Pain Control, Fitness for Discharge, Actual Discharge Time, PCA Use, Anti Emetic Use, Non-opioid Analgesic Use and Suspected Technical Failures [ Time Frame: Patient Global Assessment of Method of Pain Control,assessed at the end of treatment; Fitness for Discharge, PCA Use, Anti Emetic use, non-opioid analgesic, suspected technical failures assessed throughout; Nurse ease of care; use of rescue medication. ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 002 Drug: Morphine IV PCA
as per routine practice, up to a maximum total of 20mg morphine per 2 hours
Experimental: 001 Drug: Ionsys
40 mcg Fentanyl per on-demand dose up to a maximum of 240 mcg/ hour

Detailed Description:

This is a randomised (study medication assigned by chance), multicentre, open-label, active-controlled, parallel group study. Approximately 200 patients with expected acute moderate to severe post operative pain after an elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) will be included. Eligible patients will be randomised to receive either Ionsys or morphine IV PCA. The primary effectiveness endpoint is the patient's ability to mobilise assessed using three validated questions at the time of study treatment discontinuation. This will be summarised by treatment group at each time point post dose, with the assessment at the time of study treatment discontinuation analysed as detailed below. The difference in mobility between the two treatment groups will be assessed using an Analysis of Covariance (ANCOVA) adjusted for the indication (type of surgery). Treatment difference will be presented with a 95 percent confidence interval. The secondary endpoints will be: Ability to mobilise by surgery type; Pain intensity measured on an 11-point scale; Time to fitness for discharge; time to final discharge; Nurse Ease Of Care questionnaire; Patient global assessment of method of pain control; use of post-operative non-opioid analgesics; use of post-operative antiemetics; use of rescue morphine. Patient safety will be assessed using vital signs, adverse events, concomitant medications and non routine events. Ionsys(iontophoretic transdermal system), delivers 40 mcg fentanyl per on-demand dose up to a maximum of 240 mg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24-hour period. A new system will be applied every 24 hours, if required. If the patient has used 80 doses in less than 24 hours a new system can be applied earlier. Morphine IV PCA: Morphine bolus doses will be delivered as per local standard of care. Treatment duration will be 24-72 hours.

  Eligibility

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

Inclusion Criteria:

  • Patients, after an elective abdominal hysterectomy or unilateral primary total hip arthroplasty
  • American Society of Anesthesiology (ASA) pre-operative physical status I or II
  • Expected to have acute moderate to severe post-operative pain requiring parenteral opioids via PCA for at least 24 hours after surgery
  • Patient able to provide written consent
  • General anaesthesia, spinal anaesthetic of less than or equal to 4 hours duration of action or epidural anaesthesia (single administration only)
  • Respiratory rate 10 to 24 breaths per minute
  • SpO2 = 95 percent (with or without supplemental oxygen) and Pain score less than or equal to 4 out of 10 on a NRS after titration to comfort with IV morphine.

Exclusion Criteria:

  • Revision of a previous hip arthroplasty
  • Surgery secondary to malignancy or trauma
  • History of psychological opioid dependence and/or known or suspected to be opioid dependent
  • Known to be opioid tolerant (in the opinion of the investigator) before entering the study
  • Persistent somatoform pain disorder (ICD-10 code F45.4)
  • Severe chronic obstructive respiratory symptoms susceptibility to respiratory depression, moderate to severe renal 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 mg morphine IV) during titration to comfort, or more than 6 hours have elapsed since the patient arrived in the recovery room or Monoamine oxidase inhibitors (MAOI) within 14 days pre-study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766506

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: Medical Advisor, Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00766506     History of Changes
Other Study ID Numbers: CR015211
Study First Received: October 3, 2008
Last Updated: May 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen-Cilag Ltd.:
IONSYS
Fentanyl
Morphine
PCA
Abdominal hysterectomy
Unilateral primary total hip arthroplasty
Post operative
Pin
Mobilisation
Fitness for discharge

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 February 09, 2012