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

This study has been terminated.
(Study was terminated at the request of the company due to the recall of marketed product in Europe.)
Sponsor:
Information provided by (Responsible Party):
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00665522
First received: April 22, 2008
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Pain
Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebo
Drug: IV PCA with standard of care opioid analgesia
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl)

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • 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. [ Time Frame: Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation. ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
fentanyl iontophoretic transdermal system (40mcg) No Placebo 40 mcg per dose maximum of 6 doses/hourtotal maximum 80 doses/24 hours
Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebo
40 mcg per dose, maximum of 6 doses/hour
002
IV PCA with standard of care opioid analgesia per 24 hour period
Drug: IV PCA with standard of care opioid analgesia
total maximum 80 doses/24 hours

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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:

- Pain resulting from emergency surgery

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665522

Locations
Austria
Feldkirch, Austria
Graz, Austria
Klagenfurt, Austria
Linz, Austria
Salzburg, Austria
Wels N/A, Austria
Wien, Austria
Wr Neustadt N/A, Austria
Finland
Helsinki, Finland
Kuopio N/A, Finland
Germany
Aachen, Germany
Bad Dürkheim, Germany
Bergisch Gladbach, Germany
Berlin, Germany
Bonn, Germany
Hamburg N/A, Germany
Hannover, Germany
Kaiserslautern, Germany
Koblenz, Germany
Köln, Germany
München, Germany
Neubrandenburg, Germany
Sinsheim, Germany
Speyer, Germany
Wÿrzburg, Germany
Netherlands
Sneek, Netherlands
Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

Additional Information:
No publications provided

Responsible Party: Alza Corporation, DE, USA
ClinicalTrials.gov Identifier: NCT00665522     History of Changes
Other Study ID Numbers: CR013201, C-2006-001
Study First Received: April 22, 2008
Last Updated: April 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:
Pain
Postoperative Analgesia
Patient-Controlled Opioids

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 30, 2015