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). |
| >Trial ID | >Title | >Status | >Sponsor | >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 |
| Rotator Cuff Injury | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for Monodox
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Clinical Trial Sponsors for Monodox
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