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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR TETRACYCLINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Tetracycline Hydrochloride

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 NCT04716426 ↗ APT™ T3X on the COVID-19 Contamination Rate Completed Santa Casa de Misericórdia de Porto Alegre N/A 2021-01-28 The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic. The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes with non-prescription medications. The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides improved dermal penetration and efficacy of topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective method of destruction of microbes. These unique properties impart the broad spectrum anti-viral capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and virology. The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered, Non-Prescription product. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population. Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.
OTC NCT04716426 ↗ APT™ T3X on the COVID-19 Contamination Rate Completed University of Nove de Julho N/A 2021-01-28 The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic. The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes with non-prescription medications. The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides improved dermal penetration and efficacy of topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective method of destruction of microbes. These unique properties impart the broad spectrum anti-viral capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and virology. The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered, Non-Prescription product. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population. Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tetracycline Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000120 ↗ Clinical Trial of Eye Prophylaxis in the Newborn Completed National Eye Institute (NEI) Phase 3 1985-01-01 To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye infections. To compare side effects of the two prophylactic agents.
NCT00001683 ↗ A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients With Refractory Metastatic Cancer Completed National Cancer Institute (NCI) Phase 1 1997-10-01 Matrix metalloproteinases (MMPs) are a class of membrane bound enzymes that are involved in the degradation of the extracellular matrix. MMP-2 and MMP-9 have been associated with the progression of cancer. It is hypothesized than an imbalance between MMPs and MMP inhibitors allows the destruction of the extracellular matrix and enhances the ability of the tumor cells to grow and metastasize. By inhibiting MMPs, it is thought that angiogenesis and metastasis can be inhibited. This is a phase I study of COL-3, an oral matrix metalloproteinase inhibitor, in patients with refractory metastatic cancer. COL-3 is a chemically modified tetracycline derivative. Patients must have clinically progressive disease documented within 1 month prior to entry to be eligible for treatment. Patients must have also failed therapy of proven efficacy for their disease and have an ECOG performance status of less or equal than 2. Patients must be willing to travel from their home to the NIH for follow-up visits. Patients with brain metastases or primary CNS malignancies are not eligible. Concurrent therapy for their cancer (i.e., radiation therapy, chemotherapy, etc.) will preclude participation. We will be defining the maximum tolerated dose, the toxicity profile, characterizing the pharmacokinetics, and evaluating the effect of COL-3 on several biological endpoints.
NCT00002682 ↗ Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach Completed National Cancer Institute (NCI) Phase 2 1995-08-10 RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tetracycline Hydrochloride

Condition Name

Condition Name for Tetracycline Hydrochloride
Intervention Trials
Helicobacter Pylori Infection 50
Schizophrenia 5
Malaria 4
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Condition MeSH

Condition MeSH for Tetracycline Hydrochloride
Intervention Trials
Helicobacter Infections 44
Infections 39
Infection 35
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Clinical Trial Locations for Tetracycline Hydrochloride

Trials by Country

Trials by Country for Tetracycline Hydrochloride
Location Trials
United States 147
Taiwan 25
China 25
Canada 12
Brazil 8
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Trials by US State

Trials by US State for Tetracycline Hydrochloride
Location Trials
California 16
Texas 9
Massachusetts 8
Ohio 7
Florida 7
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Clinical Trial Progress for Tetracycline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tetracycline Hydrochloride
Clinical Trial Phase Trials
Phase 4 78
Phase 3 30
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Tetracycline Hydrochloride
Clinical Trial Phase Trials
Completed 106
Recruiting 28
Unknown status 28
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Clinical Trial Sponsors for Tetracycline Hydrochloride

Sponsor Name

Sponsor Name for Tetracycline Hydrochloride
Sponsor Trials
National Taiwan University Hospital 12
University of California, San Francisco 8
Mackay Memorial Hospital 6
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Sponsor Type

Sponsor Type for Tetracycline Hydrochloride
Sponsor Trials
Other 312
Industry 38
NIH 18
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