Last Updated: August 3, 2026

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
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 4
Helicobacter Pylori Infection 3
Refractory Chronic Cough 3
Cough 3
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Condition MeSH

Condition MeSH for citric acid; urea c-13
Intervention Trials
Cough 6
Xerostomia 5
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 48
United Kingdom 7
Israel 5
Spain 5
Egypt 5
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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
PHASE4 3
PHASE2 2
PHASE1 5
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Clinical Trial Status

Clinical Trial Status for citric acid; urea c-13
Clinical Trial Phase Trials
Completed 43
RECRUITING 8
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 93
Industry 30
NIH 7
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Last updated: July 28, 2026

Citric Acid; Urea C-13 clinical trials update, market analysis, and market projection

Citric Acid; Urea C-13 is a radiolabeled diagnostic used in urea breath testing for evaluation of Helicobacter pylori infection and related GI indications. No complete, reliable dataset can be produced here for a current clinical-trials update or quantified market forecast (trial identifiers, enrollment status, timelines, FDA/EMA status, and commercial revenue baselines) using only the information available in this request.

What is Citric Acid; Urea C-13 and what indications does it serve in diagnostics?

Citric Acid; Urea C-13 is administered as part of a breath test workflow. It is intended to enable detection of urease activity through C-13 labeled urea metabolism, with citric acid used in the test regimen.

Is it approved in the US or EU under a specific brand/NDC?

A market and trials update requires the specific marketed product identifiers (brand name, NDA/BLA, strength, dosage form, and regulator databases). Those are not provided, so approval, Orange Book style status, and prescribing use cannot be stated accurately.

Which clinical setting is it used in?

A precise setting (primary care screening, GI specialty diagnostics, post-treatment confirmation, or test-and-treat pathways) depends on label language and clinical guidance tied to a specific product.

What clinical trials have been conducted for Citric Acid; Urea C-13, and what is the latest update?

A clinical trials update requires trial-level data (NCT/CTIS identifiers, sponsor, enrollment, endpoints, start and completion dates, and results). The request does not include a source product, indication, or trial IDs.

Are there Phase 1, Phase 2, or Phase 3 studies for this drug?

Citric acid and C-13 urea products are often diagnostic rather than therapeutic. Determining phase structure and recency requires specific trial records tied to the exact product and formulation.

What endpoints matter for urea breath test diagnostics?

Typical endpoints include diagnostic sensitivity/specificity, concordance with endoscopy-based tests, and performance in eradication confirmation windows. These must be mapped to specific studies to summarize evidence quality.

When do Citric Acid; Urea C-13 products lose exclusivity, and is there biosimilar or generic risk?

Exclusivity analysis depends on whether the product is protected by an NDA (and which patents are listed), or whether it is a radiopharmaceutical/diagnostic approved via different pathways. No product listing or patent identifiers are provided.

Is there an Orange Book listing for this diagnostic?

Orange Book-style exclusivity and generic risk cannot be generated without NDA number and listing details.

Is there any biosimilar pathway here?

Biosimilar frameworks apply to biologics; C-13 urea diagnostics typically are not biologics. A definitive pathway comparison requires the regulatory designation for the specific marketed product.

What is the patent estate for Citric Acid; Urea C-13 and how strong is it?

Patent strength requires:

  • patent numbers
  • assignees
  • filing/grant dates
  • claim scope (composition, method of use, kit, manufacturing)
  • remaining life in each jurisdiction None are included in the request.

How does Citric Acid; Urea C-13 compare with alternative H. pylori diagnostics for market positioning?

Market projection requires defining the competitive set:

  • stool antigen tests
  • rapid urease tests
  • serology
  • other urea breath tests (carbon-13 vs carbon-14)
  • endoscopy-based detection

No specified comparators, geographies, or current market share baselines are provided.

Which companies supply Citric Acid; Urea C-13 and what are the commercial drivers?

Company list and commercial drivers require product-level commercial intelligence (distribution networks, reimbursement coverage, and procurement channels). Those inputs are not provided.

What reimbursement or guideline positioning drives demand?

Guideline adoption is measurable through reimbursement status and formulary placement, which requires country-level market data tied to a specific product.

What generic entry risks exist for Citric Acid; Urea C-13 and what litigation affects it?

Paragraph IV litigation risk assessment needs:

  • known ANDA/ANDA-derivative attempts
  • suit dockets
  • settlement agreements
  • any INPADOC/EPO oppositions No legal docket or regulatory filing data is included.

What regulatory status does Citric Acid; Urea C-13 have with the FDA and EMA?

Regulatory status requires the exact approved product record:

  • application type (NDA, ANDA, supplement)
  • approval date
  • current label status
  • postmarketing changes
  • manufacturing site approvals and compliance history

No regulator identifiers are provided.

What market size, adoption curve, and revenue projection applies to Citric Acid; Urea C-13?

A forecast requires a defined geography, time horizon, and unit economics, such as:

  • current annual units or revenue by country
  • number of tests performed per year
  • pricing per test (or per kit)
  • reimbursement dynamics
  • competitive mix
  • procurement and tender schedules None of these inputs or reference points are included.

Baseline, forecast scenario, and drivers

Without baseline sales, pricing, and utilization assumptions, market projection cannot be produced with accuracy.

Key Takeaways

  • Citric Acid; Urea C-13 is a urea breath test diagnostic using C-13 labeled urea in a citric acid test regimen.
  • This request does not supply product identifiers, regulatory records, trial IDs, patent data, or market baselines needed to generate a valid clinical-trials update or quantified market projection.

FAQs

  1. How do C-13 urea breath tests compare with stool antigen tests for H. pylori eradication confirmation?
  2. What are the typical sensitivity and specificity ranges reported for C-13 urea breath tests in different H. pylori prevalence settings?
  3. Which factors change urea breath test accuracy (recent antibiotics, PPIs, timing after eradication therapy)?
  4. How do pricing and reimbursement structures for diagnostic kits vary by country for H. pylori testing?
  5. What regulatory pathway differences affect approval of diagnostic urea breath test products across the US and EU?

References

  1. No sources were provided or cited in the request.

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