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Unable to recruit sufficient participants due to lack of funding; PI has left the institution.
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The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.
N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP and NAC combination | Experimental | N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill |
|
| APAP and Placebo combination | Placebo Comparator | N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APAP and NAC combination | Drug | APAP 650mg and NAC 600mg combination oral tablet administered once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo | 6 hours after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in liver function tests after study drug administration between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo | Change in serum total protein (TP), albumin (Alb), total bilirubin (TB), direct bilirubin (DB), amino alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatate (AP) levels before and after the study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Chang, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18163234 | Background | Bronstein AC, Spyker DA, Cantilena LR Jr, Green J, Rumack BH, Heard SE. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clin Toxicol (Phila). 2007 Dec;45(8):815-917. doi: 10.1080/15563650701754763. | |
| 3059186 | Background | Smilkstein MJ, Knapp GL, Kulig KW, Rumack BH. Efficacy of oral N-acetylcysteine in the treatment of acetaminophen overdose. Analysis of the national multicenter study (1976 to 1985). N Engl J Med. 1988 Dec 15;319(24):1557-62. doi: 10.1056/NEJM198812153192401. |
| Label | URL |
|---|---|
| Acetaminophen overdose information from the NIH | View source |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D017114 | Liver Failure, Acute |
| D056486 | Chemical and Drug Induced Liver Injury |
| D005334 | Fever |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| APAP and Placebo | Drug | APAP 650mg and Placebo combination oral tablet administered once |
|
|
| Within 24 hours of study drug administration |
| 7658783 | Background | Vale JA, Proudfoot AT. Paracetamol (acetaminophen) poisoning. Lancet. 1995 Aug 26;346(8974):547-52. doi: 10.1016/s0140-6736(95)91385-8. No abstract available. |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |