Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Cumberland Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
Research Team
AW
Art Wheeler, MD
Principal Investigator
Cumberland Pharmaceuticals, Inc.
Eligibility Criteria
Inclusion Criteria
1) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity
Treatment Details
Interventions
- Acetadote (Mucolytic Agent)
- Acetadote EF (Mucolytic Agent)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Acetadote without EDTAExperimental Treatment1 Intervention
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Group II: AcetadoteActive Control1 Intervention
Acetadote \[Old formulation containing EDTA\]
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cumberland Pharmaceuticals
Lead Sponsor
Trials
63
Recruited
9,400+
A.J. Kazimi
Cumberland Pharmaceuticals
Chief Executive Officer since 1999
B.S. from the University of Notre Dame, MBA from Vanderbilt University Owen Graduate School of Management
Ines Macias-Perez
Cumberland Pharmaceuticals
Chief Medical Officer
Ph.D. in Cancer Biology from Vanderbilt University