CLINICAL TRIALS PROFILE FOR OXYTETRACYCLINE HYDROCHLORIDE

All Clinical Trials for OXYTETRACYCLINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	James Graham Brown Cancer Center	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	University of Louisville	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	Julio Ramirez	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT01032499 ↗	Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir	Unknown status	Laboratorios Goulart S.A.	Phase 3	2010-05-01	To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
NCT00570648 ↗	A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization	Completed	University of Virginia	N/A	2007-06-01	Hypothesis: 1% sodium hyaluronate (Healon), applied at end of surgery to the surface of a corneal transplant will not shorten graft reepithelialization time when compared to coating with nothing. We also wish to measure and compare visual acuity in this immediate post operative period. We also wish to assess the safety of using this agent on the epithelium post-operatively. We will recruit 50 high risk patients (see inclusion criteria) here at the University of Virginia to randomly receive nothing or sodium hyaluronate (Healon) on the ocular surface at the end of surgery, and follow time to reepithelialization of the corneal transplant grafts.

Clinical Trial Conditions for OXYTETRACYCLINE HYDROCHLORIDE

Condition Name

Condition Name for OXYTETRACYCLINE HYDROCHLORIDE
Intervention	Trials
Acne Vulgaris II or III Degree	1
Atrial Fibrillation	1
Boils	1
Corneal Transplantation	1

Condition MeSH

Condition MeSH for OXYTETRACYCLINE HYDROCHLORIDE
Intervention	Trials
Surgical Wound	1
Osteitis	1
Dry Socket	1
Osteomyelitis	1

Clinical Trial Locations for OXYTETRACYCLINE HYDROCHLORIDE

Trials by Country

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−

Trials by Country for OXYTETRACYCLINE HYDROCHLORIDE
Location	Trials
Brazil	3
United States	2
Norway	1

Trials by US State

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−

Trials by US State for OXYTETRACYCLINE HYDROCHLORIDE
Location	Trials
Kentucky	1
Virginia	1

Clinical Trial Progress for OXYTETRACYCLINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for OXYTETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for OXYTETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Unknown status	1

Clinical Trial Sponsors for OXYTETRACYCLINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for OXYTETRACYCLINE HYDROCHLORIDE
Sponsor	Trials
Federal University of São Paulo	1
James Graham Brown Cancer Center	1
University of Louisville	1

Sponsor Type

Sponsor Type for OXYTETRACYCLINE HYDROCHLORIDE
Sponsor	Trials
Other	7
Industry	1

Oxytetracycline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Oxytetracycline hydrochloride is a broad-spectrum antibacterial drug widely used in both human and veterinary medicine. This article delves into the clinical trials, market analysis, and projections for this essential pharmaceutical compound.

Clinical Trials and Pharmacokinetics

Pharmacokinetic Studies

Recent studies have focused on the pharmacokinetics of oxytetracycline hydrochloride, particularly in veterinary contexts. A study on Kilis goats investigated the pharmacokinetic parameters of conventional and long-acting (LA) oxytetracycline formulations. The study involved intravenous (IV) and intramuscular (IM) administration of conventional formulations and IM administration of LA formulations. The results showed significant differences in pharmacokinetic parameters, with the LA formulation having a longer half-life compared to conventional formulations[1].

Key Findings

• The half-life of the LA formulation was significantly longer (27.96 ± 11.66 hours) compared to the conventional IV and IM formulations (10.84 ± 3.20 hours and 10.47 ± 1.30 hours, respectively)[1].
• Peak plasma concentrations and time to reach maximal plasma drug concentration also varied significantly between the different administration routes[1].

Market Analysis

Current Market Trends

The global oxytetracycline hydrochloride market is experiencing growth driven by increasing demand in both human healthcare and aquaculture sectors.

• Demand and Pricing: Prices of oxytetracycline hydrochloride are expected to increase due to rising demand and production costs. In the US and Europe, market participants anticipate higher prices as inventories decrease and end-user inquiries increase[2].
• Regional Growth: The Asia Pacific region is forecasted to witness the highest growth due to growing demand for livestock and poultry products and increasing government spending on healthcare[5].

Market Segmentation

The oxytetracycline hydrochloride market is segmented based on type, application, and end-use.

• Pharmaceutical Grade: This segment is expected to witness the highest growth due to its widespread application in treating a range of bacterial infections[5].
• Applications: The market includes segments such as oxytetracycline hydrochloride capsules, tablets, injections, and veterinary use applications. Capsules are expected to remain the largest segment due to their anti-inflammatory and antibacterial qualities[5].

Competitive Landscape

Major players in the market, such as Jiangsu Lianhuan Pharma and Kepro, are focusing on expanding their manufacturing facilities, investing in R&D, and leveraging integration opportunities across the value chain to cater to increasing demand and ensure competitive effectiveness[3][5].

Market Projections

Growth Rate and Market Size

The global oxytetracycline hydrochloride market is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030. The market size is expected to reach an estimated value of several billion dollars by 2030[5].

Forecast Analysis

Market trends from 2018 to 2023 and forecasted data from 2024 to 2030 indicate a positive outlook driven by growing demand in various sectors. The pharmaceutical grade segment is expected to dominate the market due to its extensive use in treating bacterial infections[5].

Regional Analysis

The market breakdown by region shows that Asia Pacific will lead the growth, followed by North America and Europe. This growth is attributed to the increasing demand for livestock and poultry products and rising government spending on healthcare in the APAC region[5].

Technological and Regulatory Trends

Technological Advancements

Companies are investing in research and development to improve the manufacturing process and develop innovative products. This includes advancements in formulation technology, such as the development of long-acting formulations, which have shown improved pharmacokinetic profiles[1].

Regulatory Environment

Environmental and safety regulations play a crucial role in shaping the chemical industry. Compliance with these regulations is essential for businesses operating in the oxytetracycline hydrochloride market. Regulatory changes and raw material availability are key factors influencing market dynamics[3].

Conclusion

Oxytetracycline hydrochloride is a vital antibiotic with a strong market presence and growth potential. The pharmacokinetic studies highlight the importance of formulation type and administration route in achieving optimal therapeutic outcomes. The market analysis indicates a positive outlook driven by increasing demand in human healthcare and aquaculture, with the Asia Pacific region leading the growth.

Key Takeaways

• Pharmacokinetics: Long-acting formulations of oxytetracycline hydrochloride have longer half-lives and different pharmacokinetic profiles compared to conventional formulations.
• Market Growth: The global market is expected to grow at a CAGR of 6.5% from 2024 to 2030, driven by increasing demand in human healthcare and aquaculture.
• Regional Focus: Asia Pacific is expected to witness the highest growth due to increasing demand for livestock and poultry products.
• Competitive Landscape: Major players are focusing on R&D, manufacturing expansion, and integration across the value chain to maintain competitiveness.

FAQs

What are the primary applications of oxytetracycline hydrochloride?

Oxytetracycline hydrochloride is used to treat infections caused by a variety of Gram-positive and Gram-negative microorganisms, including respiratory infections, and is also used in veterinary medicine[4].

What is the expected growth rate of the global oxytetracycline hydrochloride market?

The global oxytetracycline hydrochloride market is expected to grow at a CAGR of 6.5% from 2024 to 2030[5].

Which region is expected to lead the growth in the oxytetracycline hydrochloride market?

The Asia Pacific region is expected to witness the highest growth due to growing demand for livestock and poultry products and increasing government spending on healthcare[5].

What are the key drivers for the oxytetracycline hydrochloride market?

The major drivers for this market are growing demand in aquaculture and human healthcare sectors, along with increasing production and rising raw material costs[2][5].

Which segment is expected to dominate the oxytetracycline hydrochloride market?

The pharmaceutical grade segment is expected to witness the highest growth due to its widespread application in treating a range of bacterial infections[5].

Sources

1. Pharmacokinetics of Conventional and Long-Acting Oxytetracycline in Kilis Goats. Frontiers in Veterinary Science, 2017.
2. Oxytetracycline Hydrochloride Prices Increase in the US and Europe Amid Rise in Demand. ChemAnalyst, 2023.
3. Global Oxytetracycline Hydrochloride Market Report 2024. Cognitivemarketresearch.com.
4. Oxytetracycline: Uses, Interactions, Mechanism of Action. DrugBank.
5. Oxytetracycline Hydrochloride Market Report: Trends, Forecast and Opportunities. Lucintel.