CLINICAL TRIALS PROFILE FOR OFIRMEV

505(b)(2) Clinical Trials for OFIRMEV

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02994940 ↗	Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen	Completed	University of California, Davis	Phase 4	2017-08-28	Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.

All Clinical Trials for OFIRMEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01500109 ↗	Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair	Completed	Loma Linda University	N/A	2011-11-01	The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.
NCT01520298 ↗	Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients	Withdrawn	Lancaster General Hospital	Phase 3	2011-12-01	This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.
NCT01527942 ↗	Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients	Terminated	Saint Francis Care	N/A	2012-03-01	Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
NCT01544062 ↗	IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery	Completed	Mallinckrodt	Phase 4	2012-07-01	Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.

Clinical Trial Conditions for OFIRMEV

Condition Name

Condition Name for OFIRMEV
Intervention	Trials
Pain	9
Postoperative Pain	7
Pain, Postoperative	6
Acute Pain	4

Condition MeSH

Condition MeSH for OFIRMEV
Intervention	Trials
Pain, Postoperative	23
Acute Pain	5
Fever	2
Gastric Outlet Obstruction	2

Clinical Trial Locations for OFIRMEV

Trials by Country

Trials by Country for OFIRMEV
Location	Trials
United States	80

Trials by US State

Trials by US State for OFIRMEV
Location	Trials
New York	12
Pennsylvania	9
California	8
Ohio	8
Texas	7

Clinical Trial Progress for OFIRMEV

Clinical Trial Phase

Clinical Trial Phase for OFIRMEV
Clinical Trial Phase	Trials
Phase 4	40
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for OFIRMEV
Clinical Trial Phase	Trials
Completed	36
Terminated	10
Unknown status	7

Clinical Trial Sponsors for OFIRMEV

Sponsor Name

Sponsor Name for OFIRMEV
Sponsor	Trials
Mallinckrodt	13
Beth Israel Deaconess Medical Center	2
University of Central Florida	2

Sponsor Type

Sponsor Type for OFIRMEV
Sponsor	Trials
Other	70
Industry	18
NIH	2