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Last Updated: April 5, 2025

CLINICAL TRIALS PROFILE FOR PERIOSTAT


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All Clinical Trials for PERIOSTAT

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00358462 ↗ Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2007-01-01 The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00358462 ↗ Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA) Completed University of Washington Phase 3 2007-01-01 The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00246740 ↗ Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting Completed University of Alberta Phase 2 2005-10-01 The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB).
NCT00041977 ↗ Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea Completed CollaGenex Pharmaceuticals Phase 3 2002-06-01 The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
NCT02388477 ↗ Trial of the Use of Doxycycline After Rotator Cuff Repair Withdrawn Milton S. Hershey Medical Center N/A 1969-12-31 The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for PERIOSTAT

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2Malignant Neoplasms of Respiratory and Intrathoracic OrgansAcne RosaceaMalignant Neoplasms of Male Genital OrgansAdvanced Cancers[disabled in preview]
Condition Name for PERIOSTAT
Intervention Trials
Malignant Neoplasms of Respiratory and Intrathoracic Organs 2
Acne Rosacea 1
Malignant Neoplasms of Male Genital Organs 1
Advanced Cancers 1
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Condition MeSH

22210-0.200.20.40.60.811.21.41.61.822.2Pleural Effusion, MalignantNeoplasmsPleural EffusionReperfusion Injury[disabled in preview]
Condition MeSH for PERIOSTAT
Intervention Trials
Pleural Effusion, Malignant 2
Neoplasms 2
Pleural Effusion 2
Reperfusion Injury 1
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Clinical Trial Locations for PERIOSTAT

Trials by Country

+
Trials by Country for PERIOSTAT
Location Trials
United States 9
Canada 1
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Trials by US State

+
Trials by US State for PERIOSTAT
Location Trials
Texas 3
Pennsylvania 2
Washington 1
Virginia 1
Kentucky 1
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Clinical Trial Progress for PERIOSTAT

Clinical Trial Phase

16.7%33.3%16.7%33.3%00.911.11.21.31.41.51.61.71.81.922.1Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for PERIOSTAT
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 1
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Clinical Trial Status

42.9%28.6%14.3%14.3%00.811.21.41.61.822.22.42.62.833.2CompletedRecruitingTerminated[disabled in preview]
Clinical Trial Status for PERIOSTAT
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for PERIOSTAT

Sponsor Name

trials0112233M.D. Anderson Cancer CenterCollaGenex PharmaceuticalsUniversity of Alberta[disabled in preview]
Sponsor Name for PERIOSTAT
Sponsor Trials
M.D. Anderson Cancer Center 3
CollaGenex Pharmaceuticals 1
University of Alberta 1
[disabled in preview] 2
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Sponsor Type

54.5%27.3%18.2%00123456OtherIndustryNIH[disabled in preview]
Sponsor Type for PERIOSTAT
Sponsor Trials
Other 6
Industry 3
NIH 2
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Clinical Trials, Market Analysis, and Projections for Periostat

Introduction

Periostat, a formulation of doxycycline hyclate, is a significant drug in the treatment of periodontal disease. Here, we will delve into the clinical trials that have shaped its use, analyze the current market, and provide projections for its future.

Clinical Trials Overview

Phase 3 Clinical Trials

The efficacy of Periostat as an adjunct to scaling and root planing (SRP) has been extensively studied in clinical trials. A notable double-blind, 9-month Phase 3 study involved 190 adult patients with periodontal disease. Patients were administered either 20 mg of doxycycline hyclate twice daily or a placebo, in addition to SRP in two quadrants at baseline. The study measured clinical attachment level (ALv), pocket depth (PD), and bleeding on probing (BOP) at baseline, 3, 6, and 9 months.

Key findings included:

  • Attachment Level Gain: Patients on Periostat showed a significant mean gain in ALv compared to the placebo group, particularly in sites with severe disease (≥7 mm)[1][3].
  • Pocket Depth Reduction: Periostat resulted in a greater mean decrease in PD compared to the placebo group across all disease severity strata[1][3].
  • Bleeding on Probing: The percentage of sites with BOP was lower in the Periostat group, indicating improved periodontal health[1][3].

Adverse Reactions and Safety

In clinical trials, the most frequent adverse reactions associated with Periostat included gastrointestinal disturbances, such as nausea and diarrhea. However, these reactions were generally mild and did not lead to significant discontinuation rates. The use of Periostat is contraindicated in patients with hypersensitivity to doxycycline, during tooth development, and in nursing mothers due to potential serious adverse reactions in infants[1][3].

Market Analysis

Current Market Size

The periodontal therapeutics market, which includes drugs like Periostat, was valued at approximately USD 849.2 million in 2023. This market is segmented by product, type, distribution channel, and region[2].

Growth Drivers

The periodontal therapeutics market is driven by several factors:

  • Increasing Prevalence of Periodontal Disease: The rising incidence of periodontal diseases, often linked to poor oral hygiene and other health conditions, is a significant driver.
  • Advancements in Treatment Options: The development of adjunctive therapies like Periostat, which enhance the effectiveness of traditional treatments like SRP, is boosting market growth.
  • Aging Population: An aging population with increased susceptibility to periodontal diseases also contributes to market expansion[2].

Market Projections

The periodontal therapeutics market is projected to grow at a CAGR of 7.7% from 2024 to 2032, reaching a value of approximately USD 1.6 billion by 2032. This growth is anticipated due to the increasing demand for effective treatments and the expanding elderly population[2].

Competitive Landscape

Market Segments

The market is segmented into various product types, including antibiotics, host modulation therapies, and other therapeutic agents. Periostat, as an antibiotic adjunct, holds a significant position in this market due to its efficacy in treating periodontal disease.

Regional Analysis

The global market is diverse, with North America and Europe being major contributors. However, the Asia-Pacific region is emerging as a significant player, driven by countries like China and India. These regions offer cost-effective options for clinical trials and treatment, which is attracting more investment and research activities[2][4].

Future Projections and Trends

Clinical Trials and Research

Future clinical trials are expected to focus on developing newer host modulation therapies that lack antibiotic activity to prevent the emergence of antibiotic-resistant microorganisms. Research is also aimed at creating potent matrix metalloproteinase (MMP) inhibitors with minimal side effects[5].

Market Expansion

The periodontal therapeutics market is expected to expand further with the introduction of new treatments and the increasing awareness of oral health. Regulatory reforms and government initiatives supporting clinical trials will also play a crucial role in market growth.

Technological Advancements

Advancements in diagnostic tools and personalized medicine are likely to enhance the effectiveness of treatments like Periostat. These technologies will help in early diagnosis and tailored treatment plans, improving patient outcomes.

Key Takeaways

  • Clinical Efficacy: Periostat has shown significant clinical benefits as an adjunct to SRP in treating periodontal disease.
  • Market Growth: The periodontal therapeutics market is projected to grow substantially, driven by increasing demand and advancements in treatment options.
  • Future Research: Future clinical trials will focus on developing new host modulation therapies and improving existing treatments.
  • Regulatory Support: Government initiatives and regulatory reforms are crucial for the expansion of the clinical trials and periodontal therapeutics market.

FAQs

What is Periostat used for?

Periostat is used as an adjunct to scaling and root planing to promote attachment level gain and reduce pocket depth in patients with periodontal disease[1][3].

What are the key findings from the Phase 3 clinical trials of Periostat?

The Phase 3 trials showed that Periostat significantly improved clinical attachment levels, reduced pocket depth, and decreased bleeding on probing compared to the placebo group[1][3].

What are the common adverse reactions associated with Periostat?

Common adverse reactions include gastrointestinal disturbances such as nausea and diarrhea. However, these are generally mild and do not often lead to discontinuation[1][3].

How is the periodontal therapeutics market projected to grow?

The market is projected to grow at a CAGR of 7.7% from 2024 to 2032, reaching a value of approximately USD 1.6 billion by 2032[2].

What are the future trends in the development of periodontal therapeutics?

Future trends include the development of new host modulation therapies that lack antibiotic activity and the integration of technological advancements in diagnostic and treatment tools[5].

Sources

  1. FDA Label for Periostat: Accessdata.fda.gov
  2. Periodontal Therapeutics Market Report: Gminsights.com
  3. Periostat Package Insert: Drugs.com
  4. Global Clinical Trials Market Report: Straitsresearch.com
  5. Host Modulation Therapy in Periodontitis: Frontiersin.org

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