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Last Updated: November 4, 2024

CLINICAL TRIALS PROFILE FOR CITRIC ACID; UREA C-13


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505(b)(2) Clinical Trials for citric acid; urea c-13

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 citric acid; urea c-13

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed Charles Drew University of Medicine and Science Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00466154 ↗ The Effect of Serum LDL Lowering on Aspirin Resistance Completed Ziv Hospital N/A 2005-07-01 Aspirin resistance is the persistent platelet activation, demonstrated by platelet function tests (1). The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can improve the effect of aspirin due to the potential decreasing of cholesterol content in the platelet membranes. Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5 days of treatment with aspirin and high LDL and triglycerides<300 mg/dL, will be enrolled. Ten healthy volunteers will be the control group.
NCT00547846 ↗ A Phase II Clinical Study of PDC-748 in Patients With Acute Cough Completed PhytoHealth Corporation Phase 2 2007-10-01 The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies. The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate PDC-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of PDC-748. This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.
NCT00583765 ↗ Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration Completed Gambro Renal Products, Inc. 2005-04-01 Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis. One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors. This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for citric acid; urea c-13

Condition Name

Condition Name for citric acid; urea c-13
Intervention Trials
XEROSTOMIA 3
Helicobacter Pylori Infection 3
Cough 3
Surgery 2
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Condition MeSH

Condition MeSH for citric acid; urea c-13
Intervention Trials
Cough 6
Xerostomia 4
Glycogen Storage Disease 3
Helicobacter Infections 2
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Clinical Trial Locations for citric acid; urea c-13

Trials by Country

Trials by Country for citric acid; urea c-13
Location Trials
United States 44
United Kingdom 7
Israel 4
Spain 4
Italy 3
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Trials by US State

Trials by US State for citric acid; urea c-13
Location Trials
Texas 6
California 5
New York 4
Ohio 3
Connecticut 3
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Clinical Trial Progress for citric acid; urea c-13

Clinical Trial Phase

Clinical Trial Phase for citric acid; urea c-13
Clinical Trial Phase Trials
Phase 4 16
Phase 3 8
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for citric acid; urea c-13
Clinical Trial Phase Trials
Completed 39
Not yet recruiting 7
Unknown status 7
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Clinical Trial Sponsors for citric acid; urea c-13

Sponsor Name

Sponsor Name for citric acid; urea c-13
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 4
University of Texas Southwestern Medical Center 3
Shiraz University of Medical Sciences 3
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Sponsor Type

Sponsor Type for citric acid; urea c-13
Sponsor Trials
Other 82
Industry 27
NIH 7
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