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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR ASCORBIC ACID

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505(b)(2) Clinical Trials for Ascorbic Acid

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
New Dosage NCT01533090 Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy Completed Catholic University of the Sacred Heart N/A 2010-04-01 The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ascorbic Acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000595 Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1978-01-01 To determine whether deferoxamine prevented the complications of transfusional iron overload.
NCT00006021 Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma Completed National Cancer Institute (NCI) Phase 1/Phase 2 2000-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00006021 Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma Completed University of Miami Phase 1/Phase 2 2000-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00085345 Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma Withdrawn Oncotherapeutics Phase 2 1969-12-31 RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs. PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
NCT00102271 Nitrite Infusion Studies Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2005-01-01 This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels) increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite on blood pressure. Healthy volunteers between 21 and 40 years of age may be eligible for this study. They must be non-smokers and have no history of high blood pressure, high cholesterol, or diabetes. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. This study is either done in the NIH Clinical Center intensive care unit or on the general clinical ward. Participants are enrolled in Part A of the study. After completion of Part A participants will be enrolled in Part B of the study. Part A: Participants lie in a reclining chair during the study. Small catheters (plastic tubes) are inserted into an artery and vein in the forearm. Another tube is placed in the vein of the opposite arm. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm. This device helps us to measure blood flow through the arm. When the blood pressure cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in both forearms. Then blood is drawn from the tube in the right vein to measure blood counts, proteins, and other chemicals. Participants then are given small doses of either saline, ascorbic acid, or a medicine called oxypurinol, a form of a drug that is often taken to prevent gout. After 30 minutes, sodium nitrite is injected in increasing doses into the artery for 30 minutes. Blood flow is measured and blood is drawn every 5 minutes during the infusion. At the end of the 30 minutes, blood is drawn from the vein every 30 minutes for 3 hours. After 3 hours, sodium nitrite infusions are restarted for 2 hours and blood flow is measured and samples collected every 30 minutes during this period. Part B: Participants lie in a reclining chair during the study. A small catheter (plastic tube) is placed in the artery of the left forearm to draw blood samples. A larger catheter called a central line is placed in a deeper vein in the neck. Another tube is advanced through the central line into the chambers of the heart, through the heart valve, and into the lung artery to measure pressures in the heart and lungs. Blood is drawn after 30 minutes to obtain baseline measurements. Then saline (sterile salt water) is put into the tube in the lung artery. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm, which helps us to measure flow through the arm. When the cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in the forearm and blood samples are drawn from the tube in the left artery to measure blood counts, proteins, and other chemicals. Subjects then breathe a mixture of oxygen and nitrogen through a facemask for 30 minutes, then room air for 30 minutes, and then the oxygen and nitrogen mixture for another 30 minutes. While breathing the mixture the second time, sodium nitrite is injected through the tube in the artery in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is drawn from the tubes in the neck. Forearm blood flow is also measured every 5 minutes. After 30 minutes, the subject breathes room air for 3 hours and 15 minutes and then the sodium nitrite is injected again in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is taken from the tube in the neck and forearm blood flow is measured
NCT00112879 Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Treating Patients With Multiple Myeloma Withdrawn The Cleveland Clinic Phase 2 1969-12-31 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ascorbic Acid

Condition Name

Condition Name for Ascorbic Acid
Intervention Trials
Sepsis 8
Colonoscopy 7
Septic Shock 6
Multiple Myeloma 5
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Condition MeSH

Condition MeSH for Ascorbic Acid
Intervention Trials
Multiple Myeloma 13
Pancreatic Neoplasms 12
Neoplasms, Plasma Cell 11
Syndrome 9
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Clinical Trial Locations for Ascorbic Acid

Trials by Country

Trials by Country for Ascorbic Acid
Location Trials
United States 102
Korea, Republic of 21
Spain 11
Italy 6
China 5
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Trials by US State

Trials by US State for Ascorbic Acid
Location Trials
Pennsylvania 9
New York 8
California 7
Arizona 7
Wisconsin 5
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Clinical Trial Progress for Ascorbic Acid

Clinical Trial Phase

Clinical Trial Phase for Ascorbic Acid
Clinical Trial Phase Trials
Phase 4 31
Phase 3 31
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Ascorbic Acid
Clinical Trial Phase Trials
Completed 66
Not yet recruiting 48
Recruiting 34
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Clinical Trial Sponsors for Ascorbic Acid

Sponsor Name

Sponsor Name for Ascorbic Acid
Sponsor Trials
National Cancer Institute (NCI) 14
Thomas Jefferson University 7
Cephalon 5
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Sponsor Type

Sponsor Type for Ascorbic Acid
Sponsor Trials
Other 265
Industry 32
NIH 21
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