A Prospective Safety Surveillance Study of Fentanyl Iontophoretic Transdermal System (40 Mcg)

Condition(s) targeted: Pain, Postoperative

Intervention: fentanyl iontophoretic transdermal system (40mcg) No Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Alza Corporation, DE, USA

Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA

Overall 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:, Email: info1@veritasmedicine.com

The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.

Official title: A Prospective Safety Surveillance Study of IONSYS™ (Fentanyl HCl)

Study design: Cohort, Prospective

Primary outcome: The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.

Detailed description: The safety of fentanyl HCl 40 mcg system has been evaluated in a number of research studies. Although this research included patients with acute moderate to severe pain after particular types of surgery, including abdominal, pelvic, and orthopedic procedures, the safety associated with use under conditions of routine post-operative clinical care may not have been completely characterized by the study database. This study will be a surveillance study on the risks associated with the usage of fentanyl HCl 40 mcg system under such conditions. Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included. Patients with planned surgery and anticipated use of opioid pain management for post-operative care who are candidates for treatment with fentanyl HCl 40 mcg system or IV PCA opioid treatment will have the study explained and may participate after giving informed consent if they meet the study entry criteria. Enrollment in the study begins prior to their surgical procedure. Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation. Data collection in this observational (non-interventional) study will begin after informed consent is obtained and admission to the study center for the surgical procedure and will continue until discontinuation of fentanyl HCl 40 mcg system or IV PCA opioid treatment. Any significant changes in medical condition will be followed until they have resolved or have become medically stable.

Patients will receive fentanyl iontophoretic transdermal system 40 mcg (fentanyl HCl 40 mcg delivered by patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses) or Intravenous Patient-Controlled Analgesia (IV PCA) opioid (medication choice, treatment regimen, and operation of the PCA pump to be consistent with standard practice at participating centers). Treatment duration to be determined by the treating physician.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients

- Planned surgery

- Planned use of fentanyl HCl 40 mcg system or IV Patient-Controlled Analgesia opioid

treatment for postoperative pain

Exclusion Criteria:

- Emergency surgery

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Klagenfurt 9026, Austria; Recruiting

Linz 4010, Austria; Recruiting

Salzburg 5020, Austria; Recruiting

Wien 1021, Austria; Not yet recruiting

Linz 4020, Austria; Recruiting

Vantaa 00029, Finland; Not yet recruiting

Helsinki 00029, Finland; Not yet recruiting

Kuopio N/A 70210, Finland; Recruiting

Helsinki 00290, Finland; Not yet recruiting

Joensuu N/A 80210, Finland; Not yet recruiting

Jyväskylä N/A 40620, Finland; Not yet recruiting

Turku 20700, Finland; Not yet recruiting

Tampere 33101, Finland; Not yet recruiting

Helsinki 00280, Finland; Recruiting

Oulu 90220, Finland; Not yet recruiting

Hyvinkää 05830, Finland; Not yet recruiting

Annecy 74000, France; Recruiting

Hannover 30625, Germany; Recruiting

Hannover 30625, Germany; Not yet recruiting

Köln 50937, Germany; Recruiting

Neubrandenburg 17036, Germany; Recruiting

Hamburg N/A 20246, Germany; Not yet recruiting

Wÿrzburg 97080, Germany; Recruiting

Aachen 52074, Germany; Recruiting

Speyer 67346, Germany; Recruiting

Bonn 53105, Germany; Not yet recruiting

Köln 51109, Germany; Recruiting

Bergisch Gladbach 51465, Germany; Not yet recruiting

Bad Dürkheim 67098, Germany; Recruiting

Dooradoyle, Ireland; Recruiting

Cork, Ireland; Not yet recruiting

Dordrecht 3318 AT, Netherlands; Not yet recruiting

Sneek 8601ZK, Netherlands; Recruiting

Bergen Op Zoom 4624 VT, Netherlands; Not yet recruiting

Roosendaal 4708 AE, Netherlands; Not yet recruiting

Nl - 1105 Az Amsterdam Amsterdam, Netherlands; Not yet recruiting

Barcelona 08036, Spain; Not yet recruiting

Valencia 46014, Spain; Not yet recruiting

Cádiz, Spain; Not yet recruiting

Madrid 28046, Spain; Not yet recruiting

Madrid 28007, Spain; Not yet recruiting

Warwick CV34 5BW, United Kingdom; Not yet recruiting

To learn how to participate in this trial please click here.

Starting date: March 2008
Ending date: September 2011
Last updated: September 25, 2008