A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fen… (NCT01804673) | Clinical Trial Compass
TerminatedPhase 4
A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
Stopped: The study was prematurely discontinued since study medication was no longer available.
Germany174 participantsStarted 2008-03
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with American Society of Anesthesiology (specialty concerned with the study of anesthetics \[drug that is used to produce loss of pain sensation\] and anesthesia \[loss of sensation or feeling\]) pre-operative physical status 1, 2 or 3
* Participants who are expected to remain hospitalized for at least 24 hours post-operatively (after the surgery)
* Participants, after an elective major surgical procedure (surgery which could be postponed or not done at all without danger to the participant), who are expected to have moderate or severe pain requiring parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours after surgery
* Participants who are capable of understanding and cooperating with the requirements of the study and operating a transdermal (through the skin) Patients-Controlled Analgesia (PCA; methods of pain relief that may be used with or in place of analgesics \[drug used to control pain\])
* Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest imaginable pain at movement of the operated limb or body region, after titration (slow increase in drug dosage, guided by participant's responses) to comfort according to current postoperative procedures
Exclusion Criteria:
* Participants allergic or hypersensitive (very sensitive) to fentanyl or cetylpyridinium chloride or to skin…
What they're measuring
1
Percentage of Participants With Global Assessment of Pain at Hour 24