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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE


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All Clinical Trials for hydrocortisone acetate; oxytetracycline hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for hydrocortisone acetate; oxytetracycline hydrochloride

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition Name for hydrocortisone acetate; oxytetracycline hydrochloride
Intervention Trials
Atrial Fibrillation 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition MeSH for hydrocortisone acetate; oxytetracycline hydrochloride
Intervention Trials
Atrial Fibrillation 1
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Clinical Trial Locations for hydrocortisone acetate; oxytetracycline hydrochloride

Trials by Country

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Trials by Country for hydrocortisone acetate; oxytetracycline hydrochloride
Location Trials
Brazil 1
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Clinical Trial Progress for hydrocortisone acetate; oxytetracycline hydrochloride

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for hydrocortisone acetate; oxytetracycline hydrochloride
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for hydrocortisone acetate; oxytetracycline hydrochloride
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for hydrocortisone acetate; oxytetracycline hydrochloride

Sponsor Name

trials000001111111Fundação de Amparo à Pesquisa do Estado de São PauloFederal University of São Paulo[disabled in preview]
Sponsor Name for hydrocortisone acetate; oxytetracycline hydrochloride
Sponsor Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
Federal University of São Paulo 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for hydrocortisone acetate; oxytetracycline hydrochloride
Sponsor Trials
Other 2
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Hydrocortisone Acetate and Oxytetracycline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Overview of Hydrocortisone Acetate and Oxytetracycline Hydrochloride

Hydrocortisone acetate and oxytetracycline hydrochloride are combined in the drug Terra-Cortril, which is a suspension used primarily for ophthalmic purposes. This combination drug integrates the antibiotic properties of oxytetracycline hydrochloride with the anti-inflammatory and immunosuppressive effects of hydrocortisone acetate[4].

Clinical Trials and Outcomes

Clinical trials and studies on Terra-Cortril have provided valuable insights into its efficacy and safety.

Healing Outcomes

A significant study indicated that sites treated with Terra-Cortril showed a higher incidence of unsuccessful healing compared to non-exposure sites. The regression model identified Terra-Cortril as a significant predictor for unsuccessful healing, with an odds ratio of 2.86. Additionally, sites treated with Terra-Cortril exhibited greater bone defects and more surgical consequences[2].

Therapeutic Areas

Terra-Cortril is indicated for various conditions, including eczema, eye infections, and gingivitis. However, its use must be carefully considered due to the potential for adverse outcomes, especially in terms of bone healing and surgical complications[2].

Mechanism of Action

Oxytetracycline Hydrochloride

Oxytetracycline hydrochloride acts as a 30S ribosomal subunit inhibitor, which means it interferes with the bacterial protein synthesis process, thereby inhibiting the growth of bacteria. It is effective against a broad spectrum of Gram-positive and Gram-negative bacteria[5].

Hydrocortisone Acetate

Hydrocortisone acetate is a glucocorticoid receptor agonist, providing anti-inflammatory and immunosuppressive effects. It is used to reduce swelling, redness, and pain associated with various inflammatory conditions[4].

Market Analysis

Market Size and Growth

The oxytetracycline hydrochloride market is projected to grow at a CAGR of 6.5% from 2024 to 2030. This growth is driven by increasing demand in pharmaceutical and veterinary applications. The market is segmented by type (pharmaceutical grade and veterinary grade), application (capsules, tablets, injections, and veterinary use), and region (North America, Europe, Asia Pacific, and the Rest of the World)[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the oxytetracycline hydrochloride market. The pandemic led to disruptions in supply chains and changes in demand patterns, which are detailed in market reports that analyze the pre-pandemic and post-pandemic market scenarios[2].

Regional Market Trends

The Asia Pacific region is expected to be a key driver of growth for the oxytetracycline hydrochloride market due to increasing healthcare expenditure and a growing demand for antibiotics. North America and Europe also remain significant markets, driven by established healthcare systems and ongoing research in antibiotic therapies[2].

Regulatory and Approval Status

Approval

Terra-Cortril is an approved drug, with its combination of hydrocortisone acetate and oxytetracycline hydrochloride cleared for ophthalmic use. The regulatory status includes compliance with various clinical and safety standards[4].

Clinical Trials and R&D

While Terra-Cortril itself is approved, ongoing research and development in the field of antibiotics and corticosteroids continue to evolve. New clinical trials and studies focus on improving efficacy, reducing side effects, and expanding therapeutic applications[1].

Analytical Methods and Quality Control

Spectrophotometric Methods

Spectrophotometric methods are used to determine the concentrations of hydrocortisone, oxytetracycline, and other components in pharmaceutical preparations. These methods are crucial for ensuring the quality and efficacy of the drug[3].

High-Performance Liquid Chromatography (HPLC)

HPLC is the most widely used analytical method for oxytetracycline hydrochloride due to its high sensitivity, selectivity, and versatility. It is recommended by official compendia for quality control and pharmacokinetic monitoring[5].

Therapeutic Applications

Infectious Diseases

Oxytetracycline hydrochloride is effective against a wide range of bacterial infections, making it a valuable treatment option for various infectious diseases. Its broad spectrum of action includes both Gram-positive and Gram-negative bacteria[5].

Eye Diseases

Terra-Cortril is specifically indicated for ophthalmic use, treating conditions such as eye infections and inflammation. The combination of antibiotic and anti-inflammatory properties makes it a useful treatment for these conditions[4].

Mouth and Tooth Diseases

The drug is also used in the treatment of gingivitis and other mouth and tooth diseases, leveraging its antibacterial and anti-inflammatory effects[2].

Key Takeaways

  • Clinical Outcomes: Terra-Cortril has shown mixed results in clinical trials, with higher rates of unsuccessful healing and surgical complications.
  • Market Growth: The oxytetracycline hydrochloride market is expected to grow at a CAGR of 6.5% from 2024 to 2030.
  • Regulatory Status: Terra-Cortril is approved for ophthalmic use, with ongoing research in the field of antibiotics and corticosteroids.
  • Analytical Methods: Spectrophotometric methods and HPLC are crucial for ensuring the quality and efficacy of the drug.
  • Therapeutic Applications: The drug is used in treating infectious diseases, eye diseases, and mouth and tooth diseases.

FAQs

What is Terra-Cortril used for?

Terra-Cortril is used primarily for ophthalmic purposes, treating conditions such as eye infections and inflammation.

What are the active ingredients in Terra-Cortril?

The active ingredients are oxytetracycline hydrochloride and hydrocortisone acetate.

What is the projected growth rate of the oxytetracycline hydrochloride market?

The market is expected to grow at a CAGR of 6.5% from 2024 to 2030.

What analytical methods are used to ensure the quality of oxytetracycline hydrochloride?

Spectrophotometric methods and High-Performance Liquid Chromatography (HPLC) are used for quality control and pharmacokinetic monitoring.

Are there any significant side effects associated with Terra-Cortril?

Yes, clinical trials have shown higher rates of unsuccessful healing and surgical complications associated with the use of Terra-Cortril.

Sources

  1. Hydrocortisone Acetate/Oxytetracycline Hydrochloride - Drug Overview. Synapse by Patsnap.
  2. Oxytetracycline Hydrochloride Market Report: Trends, Forecast and Competitive Analysis. Lucintel.
  3. Spectrophotometric determination of hydrocortisone, nystatin and oxytetracycline in synthetic and pharmaceutical preparations based on various univariate and multivariate methods. ResearchGate.
  4. Terra-Cortril: Package Insert / Prescribing Information. Drugs.com.
  5. A Critical Review of Properties and Analytical Methods for the Determination of Oxytetracycline. Repositorio UNESP.

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