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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR DOXYCYCLINE

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505(b)(2) Clinical Trials for Doxycycline

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
New Combination NCT00694694 Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed National Institute for Medical Research, Tanzania Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination NCT00694694 Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed London School of Hygiene and Tropical Medicine Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Doxycycline

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000403 Doxycycline and OA Progression Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 1996-09-01 This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.
NCT00000403 Doxycycline and OA Progression Completed National Institute on Aging (NIA) Phase 3 1996-09-01 This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.
NCT00000403 Doxycycline and OA Progression Completed Indiana University Phase 3 1996-09-01 This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs. Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.
NCT00000938 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doxycycline

Condition Name

Condition Name for Doxycycline
Intervention Trials
Acne Vulgaris 10
Acne 8
Rosacea 8
Healthy 7
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Condition MeSH

Condition MeSH for Doxycycline
Intervention Trials
Infection 19
Communicable Diseases 16
Acne Vulgaris 13
Periodontitis 11
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Clinical Trial Locations for Doxycycline

Trials by Country

Trials by Country for Doxycycline
Location Trials
United States 318
Canada 23
China 11
Slovenia 7
Netherlands 6
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Trials by US State

Trials by US State for Doxycycline
Location Trials
California 24
New York 23
Pennsylvania 19
Texas 18
Florida 17
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Clinical Trial Progress for Doxycycline

Clinical Trial Phase

Clinical Trial Phase for Doxycycline
Clinical Trial Phase Trials
Phase 4 55
Phase 3 44
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Doxycycline
Clinical Trial Phase Trials
Completed 124
Recruiting 48
Not yet recruiting 31
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Clinical Trial Sponsors for Doxycycline

Sponsor Name

Sponsor Name for Doxycycline
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 12
University Medical Centre Ljubljana 9
Anapharm 5
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Sponsor Type

Sponsor Type for Doxycycline
Sponsor Trials
Other 319
Industry 72
NIH 29
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