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Last Updated: December 8, 2019

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CLINICAL TRIALS PROFILE FOR ACETYLCYSTEINE

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505(b)(2) Clinical Trials for Acetylcysteine

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 NCT01005810 A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana Unknown status Medical University of South Carolina Phase 2 2009-09-01 This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
New Formulation NCT01118663 Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection Terminated Cumberland Pharmaceuticals Phase 3 2010-09-01 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.
OTC NCT01241513 Induced Changes in Ventilatory Responsiveness and Altitude Exposure Terminated United States Army Research Institute of Environmental Medicine Phase 4 2010-11-01 The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In this study, the FDA-approved form of ACCY will be used "off-label" (meaning in a way not approved by the FDA). This study is being conducted by researchers from the United States Army Research Institute of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber located in the basement of USARIEM. A total of approximately 30 volunteers (men and women, military and civilians) will take part in the study. They can expect to be in the study for a minimum of a few hours each day for two weeks. The investigators hypothesize that ACCY will improve ventilation and oxygenation while at altitude.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Acetylcysteine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003346 Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma Completed National Cancer Institute (NCI) Phase 2 1997-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
NCT00003346 Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma Completed Memorial Sloan Kettering Cancer Center Phase 2 1997-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
NCT00004467 Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen Completed University of Texas Phase 3 1998-06-01 OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetylcysteine

Condition Name

Condition Name for Acetylcysteine
Intervention Trials
Chronic Kidney Disease 8
Contrast Induced Nephropathy 7
Helicobacter Pylori Infection 6
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Condition MeSH

Condition MeSH for Acetylcysteine
Intervention Trials
Kidney Diseases 36
Renal Insufficiency 28
Acute Kidney Injury 21
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Clinical Trial Locations for Acetylcysteine

Trials by Country

Trials by Country for Acetylcysteine
Location Trials
United States 252
Italy 19
Canada 14
Brazil 14
Taiwan 12
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Trials by US State

Trials by US State for Acetylcysteine
Location Trials
South Carolina 21
Minnesota 17
California 17
Texas 17
Connecticut 14
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Clinical Trial Progress for Acetylcysteine

Clinical Trial Phase

Clinical Trial Phase for Acetylcysteine
Clinical Trial Phase Trials
Phase 4 64
Phase 3 43
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Acetylcysteine
Clinical Trial Phase Trials
Completed 132
Recruiting 48
Not yet recruiting 46
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Clinical Trial Sponsors for Acetylcysteine

Sponsor Name

Sponsor Name for Acetylcysteine
Sponsor Trials
Medical University of South Carolina 16
Yale University 11
National Institutes of Health (NIH) 9
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Sponsor Type

Sponsor Type for Acetylcysteine
Sponsor Trials
Other 412
NIH 40
Industry 32
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