CLINICAL TRIALS PROFILE FOR CITRIC ACID; UREA C-13

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.

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.
NCT00583765 ↗	Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration	Completed	University of Alberta		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.
NCT00645879 ↗	Anaplerotic Therapy in Propionic Acidemia	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1	2008-07-01	The objective of this project is to define whether nutritional supplements (ornithine alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients with propionic acidemia. Ornithine alpha-ketoglutarate, glutamine, and citrate are commonly used as nutritional supplements specially by athletes to increase muscle strength. They can be mixed with formula or other foods.

Clinical Trial Conditions for citric acid; urea c-13

Condition Name

Condition Name for citric acid; urea c-13
Intervention	Trials
Helicobacter Pylori Infection	3
Cough	3
Xerostomia	3
Refractory Chronic Cough	2

Condition MeSH

Condition MeSH for citric acid; urea c-13
Intervention	Trials
Cough	6
Xerostomia	4
Glycogen Storage Disease	3
Motion Sickness	2

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
China	3

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

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

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

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
Repurposed Therapeutics, Inc.	3
University of Texas Southwestern Medical Center	3

Sponsor Type

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

Citric acid; urea c-13 Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Citric Acid and Urea C-13 in the Context of the 13C-Urea Breath Test (13C-UBT)

Introduction

The 13C-urea breath test (13C-UBT) is a widely used diagnostic tool for detecting Helicobacter pylori (H. pylori) infections, which are associated with various gastrointestinal disorders. The test involves the use of urea labeled with carbon-13 (Urea C-13) and, increasingly, citric acid as a test meal to enhance its accuracy and efficiency.

Clinical Trials and Efficacy

Citric Acid as a Test Meal

Recent studies have consistently shown that using citric acid as the test meal in the 13C-UBT significantly improves the test's performance. A study published in the journal Gut demonstrated that citric acid solution yields higher and earlier peak delta values compared to semiliquid meals, indicating superior 13CO2 recovery and diagnostic accuracy[1].

Another study highlighted that citric acid enhances urease activity by delaying gastric emptying and possibly distributing the urea more effectively within the stomach. This results in higher breath 13CO2 activity, making the test more reliable[2].

A more recent study in a Chinese population confirmed that the addition of citric acid to the 13C-UBT improves the test's accuracy, particularly for patients with results in the gray zone (delta over baseline values between 4-10‰). The study showed that using citric acid eliminated false-positive results in this gray zone[3].

Dosage and Optimization

The optimal dosage of citric acid has been a focus of research. Studies suggest that even a low dose of citric acid (e.g., 1 g per 200 ml) can significantly enhance the test's simplicity and palatability without compromising its efficacy[2][3].

Market Analysis

Current Market Status

The 13C-UBT market is growing due to the increasing prevalence of H. pylori infections and the need for accurate and non-invasive diagnostic tools. The integration of citric acid into these tests has been a key factor in this growth, as it enhances the test's accuracy and patient compliance.

Product Offerings

Several products combine Urea C-13 with citric acid, such as Pranactin-Citric™, which includes 75 mg of 13C-urea and citric acid. These formulations are approved by regulatory bodies like the FDA and are widely available in the market[4][5].

Market Trends

The trend towards using citric acid in 13C-UBT is driven by its proven benefits in clinical trials. The market is expected to continue growing as more healthcare providers adopt this enhanced diagnostic method. Additionally, the non-radioactive nature of 13C-urea makes it a preferred choice over 14C-urea, especially in pregnant women and children.

Market Projections

Growth Potential

The global market for diagnostic tests for H. pylori infections is projected to grow significantly over the next few years. The adoption of citric acid in 13C-UBT is expected to be a major driver of this growth, as it offers improved diagnostic accuracy and patient comfort.

Regional Markets

The market for 13C-UBT with citric acid is expected to expand in regions with high prevalence of H. pylori infections, such as Asia and Latin America. In these regions, the simplicity and cost-effectiveness of the test, combined with the enhanced accuracy provided by citric acid, will be particularly appealing.

Competitive Landscape

The market is competitive, with several companies offering 13C-UBT kits that include citric acid. Companies like Meridian Bioscience and Richen Europe S.R.L. are key players, and the competition is expected to drive innovation and further improvements in these diagnostic tools.

Key Takeaways

• Enhanced Accuracy: Citric acid significantly improves the accuracy and speed of the 13C-UBT.
• Clinical Evidence: Multiple studies have confirmed the superiority of citric acid as a test meal.
• Market Growth: The market for 13C-UBT with citric acid is expected to grow due to its proven benefits and increasing adoption.
• Regional Expansion: High-prevalence regions will drive market expansion.
• Competitive Market: Several companies are offering competitive products, driving innovation.

FAQs

Q: What is the role of citric acid in the 13C-urea breath test?

A: Citric acid acts by delaying gastric emptying and possibly decreasing the pH at the site of the bacteria, enhancing urease activity and improving the test's accuracy and speed[1][2].

Q: How does the use of citric acid affect the diagnostic accuracy of the 13C-UBT?

A: The use of citric acid eliminates false-positive results in the gray zone and increases the sensitivity and specificity of the test, particularly for patients with borderline results[3].

Q: What are the advantages of using Urea C-13 over Urea C-14 in the breath test?

A: Urea C-13 is non-radioactive, making it safer for use in pregnant women and children, and it provides similar diagnostic accuracy without the radiation risks associated with Urea C-14[4].

Q: Which regions are expected to drive the growth of the 13C-UBT market with citric acid?

A: Regions with high prevalence of H. pylori infections, such as Asia and Latin America, are expected to drive the market growth due to the simplicity, cost-effectiveness, and enhanced accuracy of the test[3].

Q: What are some of the key products available in the market that combine Urea C-13 with citric acid?

A: Products like Pranactin-Citric™, which includes 75 mg of 13C-urea and citric acid, are widely available and approved by regulatory bodies like the FDA[4][5].

Sources

1. Gut: "A citric acid solution is an optimal test drink in the 13C-urea breath test for the diagnosis of Helicobacter pylori infection"[1].
2. PubMed: "Citric acid as the test meal for the 13C-urea breath test"[2].
3. PubMed: "Application of citric acid can enhance the accuracy for 13 C-urea breath test in the diagnosis of Helicobacter pylori infection"[3].
4. DrugBank: "Urea C-13: Uses, Interactions, Mechanism of Action"[4].
5. FDA: "20-586S004 Pranactin-Citric Statistical Review"[5].