A Prospective Safety Surveillance Study of Fentanyl Iontophoretic Transdermal System (40 Mcg)
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ClinicalTrials.gov Identifier: NCT00665522 |
Recruitment Status :
Terminated
(Study was terminated at the request of the company due to the recall of marketed product in Europe.)
First Posted : April 24, 2008
Last Update Posted : April 10, 2015
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Condition or disease | Intervention/treatment |
---|---|
Pain | Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebo Drug: IV PCA with standard of care opioid analgesia |
Study Type : | Observational |
Actual Enrollment : | 218 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl) |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

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
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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
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Drug: IV PCA with standard of care opioid analgesia
total maximum 80 doses/24 hours |
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665522
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 |
Study Director: | Alza Corporation Clinical Trial | ALZA |
Responsible Party: | Alza Corporation, DE, USA |
ClinicalTrials.gov Identifier: | NCT00665522 |
Other Study ID Numbers: |
CR013201 C-2006-001 |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | April 2015 |
Pain Postoperative Analgesia Patient-Controlled Opioids |
Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |