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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
IONSYS Fentanyl Morphine PCA Abdominal hysterectomy |
Unilateral primary total hip arthroplasty Post operative Pin Mobilisation Fitness for discharge |
|
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 |