You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR DOXYCYCLINE CALCIUM


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for doxycycline calcium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01014260 ↗ Doxycycline Outcomes in Lupus Erythematosus Withdrawn Johns Hopkins University Phase 4 2010-09-01 Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.
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.
NCT02726646 ↗ Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis Completed Pontificia Universidade Catolica de Sao Paulo Phase 2 2015-06-01 Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.
NCT02726646 ↗ Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis Completed University of Campinas, Brazil Phase 2 2015-06-01 Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for doxycycline calcium

Condition Name

Condition Name for doxycycline calcium
Intervention Trials
Hip Fractures 1
Osteoporotic Fracture of Femur 1
Trochanteric Fracture of Femur 1
Acne Vulgaris 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for doxycycline calcium
Intervention Trials
Periodontitis 1
Osteoporotic Fractures 1
Chronic Periodontitis 1
Hip Fractures 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for doxycycline calcium

Trials by Country

Trials by Country for doxycycline calcium
Location Trials
Brazil 2
United States 2
Turkey 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for doxycycline calcium
Location Trials
Texas 1
Maryland 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for doxycycline calcium

Clinical Trial Phase

Clinical Trial Phase for doxycycline calcium
Clinical Trial Phase Trials
Phase 4 4
Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for doxycycline calcium
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Withdrawn 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for doxycycline calcium

Sponsor Name

Sponsor Name for doxycycline calcium
Sponsor Trials
Vyne Therapeutics Inc. 1
Edward Lain, MD 1
Lund University Hospital 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for doxycycline calcium
Sponsor Trials
Other 8
Industry 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Doxycycline calcium Market Analysis and Financial Projection

Doxycycline Calcium: Clinical Trials, Market Analysis, and Projections

Introduction

Doxycycline calcium, a derivative of the broad-spectrum antibiotic doxycycline, has been under scrutiny for its efficacy and safety in various clinical applications. This article delves into the recent clinical trials, market analysis, and future projections for doxycycline calcium.

Clinical Trials: Efficacy and Safety

Acne Treatment

A significant clinical trial focused on the use of doxycycline calcium in treating moderate to severe inflammatory acne. This randomized, double-blind, phase 2 dose-ranging study involved subjects aged 12 to 45 years who were administered doxycycline calcium tablets at doses of 0.6, 1.2, or 2.4 mg/kg/day, or a placebo, for 12 weeks. The results showed a dose-response effect, with the highest dose group demonstrating a statistically significant reduction in inflammatory lesions compared to the placebo group[1].

Other Clinical Applications

While doxycycline has been explored for its potential in preventing arterial calcification, a recent study on patients with small aortic aneurysms did not show significant benefits. The study found that doxycycline 100 mg twice daily did not decrease circulating levels of matrix metalloproteinases (MMP-3 and MMP-9) or alter the progression of arterial calcification[4].

Market Analysis

Market Size and Growth

The doxycycline hyclate market, which includes doxycycline calcium, was valued at USD 1.2 billion in 2023 and is projected to reach USD 1.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2031. This growth is driven by the drug's broad-spectrum efficacy against various bacterial diseases, its effectiveness in treating acne and malaria, and increasing public awareness of STD treatment[2].

Market Segmentation

The market is segmented by application (antibiotics, acne treatment, malaria treatment, veterinary medicine) and product form (tablets, capsules, powder, injection formulations). Geographically, North America is a significant market, followed by Europe, Asia-Pacific, and other regions. Key players in the market include Pfizer, Novartis, GlaxoSmithKline, and Teva Pharmaceuticals, among others[2].

Factors Driving Market Growth

Several factors are propelling the growth of the doxycycline hyclate market:

  • Broad-Spectrum Efficacy: Doxycycline's effectiveness against a wide range of bacterial diseases, including respiratory and urinary tract infections.
  • Acne Treatment: The rising prevalence of acne and the need for efficient treatment alternatives.
  • Malaria Treatment: Its role in controlling parasite illnesses such as malaria.
  • Pharmaceutical Formulations: Improvements in pharmaceutical formulations and increased accessibility in both developed and developing countries.
  • Public Awareness: Rising public awareness of STD treatment, particularly in developing nations[2].

Market Projections

Future Growth Trends

The market for doxycycline hyclate is expected to continue growing due to several trends:

  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and an increase in the need for efficient antibiotics.
  • Innovative Formulations: The creation of innovative formulations and the focus on antibiotic stewardship.
  • Increased Demand: Rising demand driven by the growing incidence of infectious disorders and heightened awareness of STDs[2].

Regional Outlook

North America is anticipated to remain a major consumer of doxycycline hyclate, followed by Europe and the Asia-Pacific region. The growth in these regions is attributed to advanced healthcare systems, higher disposable incomes, and greater awareness of healthcare options[5].

Challenges and Opportunities

Generic Drug Development

The development of generic versions of doxycycline can impact market dynamics. Generic entry typically leads to lower drug prices, which can increase accessibility but may also affect the revenue of brand-name manufacturers. The cost of developing generic drugs, including activities such as reverse engineering and bioequivalence testing, is a significant factor in this process[3].

Regulatory Environment

Regulatory changes, such as those advocated by the U.S. Department of Health and Human Services to promote competition and reduce drug prices, can influence the market. For instance, increasing the rate of FDA first-cycle approvals and reducing FDA submission fees can expedite the entry of generic drugs into the market[3].

Key Takeaways

  • Clinical Efficacy: Doxycycline calcium has shown efficacy in treating moderate to severe inflammatory acne.
  • Market Growth: The doxycycline hyclate market is projected to grow at a CAGR of 4.5% from 2024 to 2031.
  • Driving Factors: Broad-spectrum efficacy, acne treatment, malaria treatment, and improvements in pharmaceutical formulations are key drivers.
  • Regional Outlook: North America and Europe are significant markets, with the Asia-Pacific region showing potential growth.
  • Challenges and Opportunities: Generic drug development and regulatory changes can impact market dynamics.

FAQs

Q: What is the primary use of doxycycline calcium in clinical trials?

A: The primary use of doxycycline calcium in clinical trials has been in the treatment of moderate to severe inflammatory acne.

Q: What is the projected market size of the doxycycline hyclate market by 2031?

A: The doxycycline hyclate market is expected to reach USD 1.8 billion by 2031.

Q: Which region is the largest consumer of doxycycline hyclate?

A: North America is the largest consumer of doxycycline hyclate globally.

Q: What factors are driving the growth of the doxycycline hyclate market?

A: The growth is driven by its broad-spectrum efficacy, effectiveness in treating acne and malaria, and improvements in pharmaceutical formulations.

Q: How does generic drug development impact the doxycycline hyclate market?

A: Generic drug development can lead to lower drug prices, increasing accessibility but potentially affecting brand-name manufacturers' revenue.

Sources

  1. PubMed: "A randomized, phase 2, dose-ranging study in the treatment of moderate to severe inflammatory facial acne vulgaris with doxycycline calcium."
  2. Market Research Intellect: "Doxycycline Hyclate Market Size, Share & Growth [2024-2031]."
  3. ASPE: "COST OF GENERIC DRUG DEVELOPMENT AND APPROVAL FINAL REPORT DECEMBER 31, 2021."
  4. PubMed: "Effect of Doxycycline on Progression of Arterial Calcification in the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA 3CT)."
  5. ChemAnalyst: "Doxycycline Hydrochloride Market Size, Share & Forecast 2034."

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.