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Sponsored by: |
Janssen Cilag N.V./S.A. |
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Information provided by: | Janssen Cilag N.V./S.A. |
ClinicalTrials.gov Identifier: | NCT00779038 |
This open-label study will evaluate in daily clinical practice the safety and efficacy of a fentanyl Iontophoretic Transdermal System (fentanyl ITS) for management of moderate to severe acute pain in postoperative patients who have undergone elective spine or orthopaedic surgery.
Condition | Intervention | Phase |
---|---|---|
Pain, Postoperative |
Drug: Fentanyl Iontophoretic Transdermal System (fentanyl ITS) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Outcome Study in Postoperative Pain Management to Demonstrate the Efficacy and Safety of IONSYS (Fentanyl ITS Iontophoretic Transdermal System) in Daily Clinical Practice and to Assess Its Convenience. |
Estimated Enrollment: | 150 |
Study Start Date: | July 2008 |
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of a fentanyl Iontophoretic Transdermal System (fentanyl ITS) for management of moderate to severe acute pain in postoperative patients who have undergone elective spine or orthopaedic surgery. There will be a focus on the analysis of the use of IV lines and the administration of intravenous medication for opioid related side effects or for additional analgesia during the use of fentanyl ITS. Therefore we will document (at each time point) the amount of patients who have an IV line and compare the actual usage of the IV line with the intended use of the IV line. The exact moment of first oral intake as well as the exact moment of discontinuation of the IV line will be recorded, if applicable.Patients are expected to require parenteral opioids for at least 48 hours postoperatively. This study will also evaluate patients', nurses' and physicians' assessment of fentanyl ITS under routine conditions.All adverse events will be documented. The delayed occurrence of application side reactions after removal of the device will be followed-up. The study treatment phase can last up to 72 hours.
40 mg fentanyl transdermally per on-demand dose, each delivered over 10 min for a maximum of 6 doses/h (240 mg/h) for 24 h or a maximum of 80 doses (3.2 mg). Each system will inactivate at 80 doses or 24 h, whichever occurs first. A new system will be applied every 24 h unless the patient has used 80 doses in less than 24 h. In this case a new system can be applied earlier. This system will be changed again at the 24 h time point. A maximum treatment duration of 72 h is allowed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Belgium | |
Active, not recruiting | |
Edegem, Belgium, 2650 | |
Recruiting | |
Brussel, Belgium, 1090 |
Study Director: | Janssen-Cilag N.V./S.A., Belgium Clinical Trial | Janssen Cilag N.V./S.A. |
Study ID Numbers: | CR015121 |
Study First Received: | October 23, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00779038 |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Postoperative pain IONSYS Fentanyl Iontophoretic Transdermal System |
Signs and Symptoms Fentanyl Postoperative Complications Pain Pain, Postoperative |
Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Pathologic Processes |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |