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Last Updated: November 2, 2024

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 Completed National Institute on Drug Abuse (NIDA) 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.
OTC NCT01005810 ↗ A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana Completed 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.
OTC NCT03238300 ↗ Neuroscience-Informed Treatment Development for Adolescent Alcohol Use Recruiting National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2017-10-16 This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 55 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. Urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. Participants will receive a 1- hour MRI scan at baseline and after each treatment trial.
>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.
NCT00004467 ↗ Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen Completed University of Texas Southwestern Medical Center 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.
NCT00004467 ↗ Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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
Oxidative Stress 9
Contrast Induced Nephropathy 8
Chronic Kidney Disease 8
COVID-19 7
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Condition MeSH

Condition MeSH for ACETYLCYSTEINE
Intervention Trials
Kidney Diseases 40
Renal Insufficiency 28
Disease 25
Acute Kidney Injury 22
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Clinical Trial Locations for ACETYLCYSTEINE

Trials by Country

Trials by Country for ACETYLCYSTEINE
Location Trials
United States 312
Italy 21
Canada 20
Brazil 18
Netherlands 15
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Trials by US State

Trials by US State for ACETYLCYSTEINE
Location Trials
California 27
South Carolina 27
New York 19
Texas 19
Minnesota 18
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Clinical Trial Progress for ACETYLCYSTEINE

Clinical Trial Phase

Clinical Trial Phase for ACETYLCYSTEINE
Clinical Trial Phase Trials
Phase 4 76
Phase 3 56
Phase 2/Phase 3 27
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Clinical Trial Status

Clinical Trial Status for ACETYLCYSTEINE
Clinical Trial Phase Trials
Completed 192
Recruiting 54
Unknown status 53
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Clinical Trial Sponsors for ACETYLCYSTEINE

Sponsor Name

Sponsor Name for ACETYLCYSTEINE
Sponsor Trials
Medical University of South Carolina 21
Yale University 11
National Institute on Drug Abuse (NIDA) 10
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Sponsor Type

Sponsor Type for ACETYLCYSTEINE
Sponsor Trials
Other 619
NIH 55
Industry 51
[disabled in preview] 20
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