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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR MONODOX


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All Clinical Trials for Monodox

Trial ID Title Status Sponsor Phase Start Date Summary
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).
NCT00652704 ↗ Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions Completed Anapharm Phase 1 1999-07-01 To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
NCT00652704 ↗ Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions Completed Par Pharmaceutical, Inc. Phase 1 1999-07-01 To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
NCT00652795 ↗ Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions Completed Anapharm Phase 1 2004-07-01 To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
NCT00652795 ↗ Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions Completed Par Pharmaceutical, Inc. Phase 1 2004-07-01 To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Monodox

Condition Name

Condition Name for Monodox
Intervention Trials
To Determine Bioequivalence Under Fasting Conditions 3
To Determine Bioequivalence Under Fed Conditions. 2
To Determine Bioequivalence Under Fed Conditions 2
Urethritis 1
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Condition MeSH

Condition MeSH for Monodox
Intervention Trials
Disease 5
Disease Susceptibility 1
Rotator Cuff Injuries 1
Malnutrition 1
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Clinical Trial Locations for Monodox

Trials by Country

Trials by Country for Monodox
Location Trials
Canada 5
United States 2
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Trials by US State

Trials by US State for Monodox
Location Trials
Pennsylvania 1
Washington 1
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Clinical Trial Progress for Monodox

Clinical Trial Phase

Clinical Trial Phase for Monodox
Clinical Trial Phase Trials
Phase 3 1
Phase 1 5
N/A 1
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Clinical Trial Status

Clinical Trial Status for Monodox
Clinical Trial Phase Trials
Completed 6
Withdrawn 1
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Clinical Trial Sponsors for Monodox

Sponsor Name

Sponsor Name for Monodox
Sponsor Trials
Anapharm 5
Par Pharmaceutical, Inc. 5
National Institute of Allergy and Infectious Diseases (NIAID) 1
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Sponsor Type

Sponsor Type for Monodox
Sponsor Trials
Industry 10
Other 2
NIH 1
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