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CLINICAL TRIALS PROFILE FOR IONSYS

Clinical Trials for Ionsys

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00665522	A Prospective Safety Surveillance Study of Fentanyl Iontophoretic Transdermal System (40 Mcg)	Terminated	Alza Corporation, DE, USA	Phase 4	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.
NCT00666393	An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients	Withdrawn	Alza Corporation, DE, USA	Phase 3	The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
NCT00708318	Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects	Completed	YM BioSciences	Phase 1	This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.
NCT00779038	Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery	Terminated	Janssen Cilag N.V./S.A.	Phase 4	The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.
NCT01804673	A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain	Terminated	Janssen-Cilag G.m.b.H	Phase 4	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.
NCT03021083	Evaluating the Feasibility of Using Transdermal Patient-controlled Fentanyl After Spinal Fusions	Not yet recruiting	The Medicines Company	Phase 4	The treatment of postoperative pain continues to be a challenge after posterior spinal fusions. There is considerable evidence demonstrating that a multi-modality approach including patient controlled analgesia (PCA) with opioids for postoperative pain management compared to conventional opioid analgesia provides a greater analgesic effect even when the amount of opioids consumed is similar between both groups. However, the PCA modality is often discontinued prior to all the patients' pain needs being met. The IONSYS system uses the concept of PCA-delivered narcotics and may be used for postoperative pain management.
NCT03021083	Evaluating the Feasibility of Using Transdermal Patient-controlled Fentanyl After Spinal Fusions	Not yet recruiting	Hospital for Special Surgery, New York	Phase 4	The treatment of postoperative pain continues to be a challenge after posterior spinal fusions. There is considerable evidence demonstrating that a multi-modality approach including patient controlled analgesia (PCA) with opioids for postoperative pain management compared to conventional opioid analgesia provides a greater analgesic effect even when the amount of opioids consumed is similar between both groups. However, the PCA modality is often discontinued prior to all the patients' pain needs being met. The IONSYS system uses the concept of PCA-delivered narcotics and may be used for postoperative pain management.
Trial ID	Title	Status	Sponsor	Phase	Summary