Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
NCT ID: NCT01118663
Last Updated: 2014-08-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
17 participants
INTERVENTIONAL
2010-09-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acetadote without EDTA
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
Acetadote
Acetadote \[Old formulation containing EDTA\]
Acetadote
Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
Interventions
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Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
Acetadote
Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
3. Pregnant or nursing.
4. Less than 12 years of age.
5. Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1000 U/L.
6. Have a baseline International Normalized. Ratio (INR) \> 2.0
7. Be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
8. Have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
9. Inability to understand the requirements of the study. Subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions. (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative).
10. Refusal to provide written authorization for use and disclosure of protected health information.
11. Be otherwise unsuitable for the study, in the opinion of the Investigator.
12 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Art Wheeler, MD
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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Maricopa Medical Center
Phoenix, Arizona, United States
Loma Linda University Medical Center
Loma Linda, California, United States
University of California Irvine Medical Center
Orange, California, United States
UCSD Medical Center
San Diego, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
East Carolina University Medical Center
Greenville, North Carolina, United States
Toledo Hospital
Toledo, Ohio, United States
Scott & White Medical Center
Temple, Texas, United States
Countries
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References
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Bhushan M, Beck MH. Allergic contact dermatitis from disodium ethylenediamine tetra-acetic acid (EDTA) in a local anaesthetic. Contact Dermatitis. 1998 Mar;38(3):183. doi: 10.1111/j.1600-0536.1998.tb05702.x. No abstract available.
van Laar T, van Hilten B, Neef C, Rutgers AW, Pavel S, Bruijn JA. The role of EDTA in provoking allergic reactions to subcutaneous infusion of apomorphine in patients with Parkinson's disease: a histologic study. Mov Disord. 1998 Jan;13(1):52-5. doi: 10.1002/mds.870130113.
Kimura M, Kawada A. Contact dermatitis due to trisodium ethylenediaminetetra-acetic acid (EDTA) in a cosmetic lotion. Contact Dermatitis. 1999 Dec;41(6):341. doi: 10.1111/j.1600-0536.1999.tb06184.x. No abstract available.
Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.
Other Identifiers
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CPI-NAC-001
Identifier Type: -
Identifier Source: org_study_id
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