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Last Updated: December 14, 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.
OTC NCT03238300 Neuroscience-Informed Treatment Development for Adolescent Alcohol Use Not yet recruiting National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2017-09-01 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). 50 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.
OTC NCT03238300 Neuroscience-Informed Treatment Development for Adolescent Alcohol Use Not yet recruiting Medical University of South Carolina Phase 2 2017-09-01 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). 50 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 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.
NCT00028262 Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 2001-02-01 This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children. At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms worsening over time. The disease results from an enzyme deficiency that causes fatty compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has helped remove ceroid from cells of patients with INCL. Children with INCL between 6 months and 3 years of age may be eligible for this study. Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH Clinical Center for a 4- to 5-day period every 6 months for the following tests and evaluations: - Review of medical history, including a detailed record of seizures, physical examination, blood tests and clinical photographs. For the initial baseline studies, examinations may also be scheduled with pediatric neurology, ophthalmology and anesthesia services. - Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves, and computers to provide detailed images of the brain without the use of X-rays. The patient lies on a table that slides inside a donut-shaped machine containing a magnetic field. The child requires general anesthesia for the procedure. - Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue in the back of the eye. To record the flash ERG, a special contact lens is placed on the eye s surface and the eye is stimulated with flashes of light. Infants and very young children require general anesthesia for the procedure. - Visual evoked potential (VEP) measures the function of the visual pathway from the eye to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is stimulated with flashes of light. Infants and very young children must be anesthetized for the procedure. - Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed on the scalp. The test is useful in defining seizures. The child may need to be sedated to keep still during the test. - Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder) under local anesthetic to grow cells in the laboratory. This procedure is done at the start of the study and is repeated after 1 year if therapy results are promising. Children s condition may improve, stabilize or worsen during this study. Life may be prolonged without significant improvement in quality. The information gained from the study may help scientists develop more potent drugs to treat INCL.
>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
Schizophrenia 6
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Condition MeSH

Condition MeSH for acetylcysteine
Intervention Trials
Kidney Diseases 36
Renal Insufficiency 28
Disease 21
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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