- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665522
A Prospective Safety Surveillance Study of Fentanyl Iontophoretic Transdermal System (40 Mcg)
April 9, 2015 updated by: Alza Corporation, DE, USA
A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl)
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Actual)
218
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Feldkirch, Austria
-
Graz, Austria
-
Klagenfurt, Austria
-
Linz, Austria
-
Salzburg, Austria
-
Wels N/A, Austria
-
Wien, Austria
-
Wr Neustadt N/A, Austria
-
-
-
-
-
Helsinki, Finland
-
Kuopio N/A, Finland
-
-
-
-
-
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
-
-
-
-
-
Sneek, Netherlands
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
001
fentanyl iontophoretic transdermal system (40mcg) No Placebo 40 mcg per dose maximum of 6 doses/hourtotal maximum 80 doses/24 hours
|
40 mcg per dose, maximum of 6 doses/hour
|
002
IV PCA with standard of care opioid analgesia per 24 hour period
|
total maximum 80 doses/24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 22, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Estimate)
April 10, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013201
- C-2006-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on fentanyl iontophoretic transdermal system (40mcg) No Placebo
-
Alza Corporation, DE, USAWithdrawnPain, Postoperative | Pediatrics
-
Janssen Pharmaceutical K.K.Completed
-
ZARS Pharma Inc.Terminated
-
Janssen Research & Development, LLCCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Mylan Pharmaceuticals IncCompleted
-
ZARS Pharma Inc.Completed
-
ZARS Pharma Inc.TerminatedPain | CancerUnited States
-
Medical University of GrazCompletedHip Fractures (ICD-10 72.01-72.2)Austria
-
Janssen-Cilag International NVAlza Corporation, DE, USACompletedPain | Pain, Postoperative | Analgesia, Patient-ControlledFrance, United Kingdom, Germany, Spain, Switzerland, Sweden, Belgium, Austria, Denmark, Ireland