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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

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 NCT01589497 ↗ Essentiality of INH in TB Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2015-06-30 Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Combination NCT01589497 ↗ Essentiality of INH in TB Therapy Completed AIDS Clinical Trials Group Phase 2 2015-06-30 Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Indication NCT03257423 ↗ Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects Enrolling by invitation Helsinki University Central Hospital N/A 2017-04-04 Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication NCT03257423 ↗ Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects Enrolling by invitation Jyväskylä Central Hospital N/A 2017-04-04 Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication NCT03257423 ↗ Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects Enrolling by invitation Kuopio University Hospital N/A 2017-04-04 Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication NCT03257423 ↗ Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects Enrolling by invitation Oulu University Hospital N/A 2017-04-04 Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00042289 ↗ Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2003-03-01 The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗ Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy Completed National Institute of Allergy and Infectious Diseases (NIAID) 2003-03-01 The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00062231 ↗ Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Terminated European Organisation for Research and Treatment of Cancer - EORTC N/A 2002-04-01 RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
NCT00082173 ↗ Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis Completed Johns Hopkins University Phase 2 2004-10-01 Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
NCT00140309 ↗ TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment Completed Centers for Disease Control and Prevention Phase 2 2003-07-01 This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
NCT00144417 ↗ TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment Completed Bayer Phase 2 2006-02-01 This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Condition Name

Condition Name for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Intervention Trials
Healthy 82
Healthy Volunteers 22
Tuberculosis 20
Healthy Subjects 20
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Condition MeSH

Condition MeSH for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Intervention Trials
Tuberculosis 49
Tuberculosis, Pulmonary 23
Cataract 21
Infections 21
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Clinical Trial Locations for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Trials by Country

Trials by Country for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Location Trials
United States 476
South Africa 103
Germany 92
China 62
United Kingdom 55
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Trials by US State

Trials by US State for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Location Trials
Texas 50
California 32
Florida 31
Maryland 26
Arizona 22
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Clinical Trial Progress for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Clinical Trial Phase Trials
Phase 4 52
Phase 3 60
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Clinical Trial Phase Trials
Completed 340
Recruiting 41
Not yet recruiting 19
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Clinical Trial Sponsors for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Sponsor Name

Sponsor Name for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Sponsor Trials
Bayer 34
GlaxoSmithKline 19
Pfizer 17
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Sponsor Type

Sponsor Type for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Sponsor Trials
Other 393
Industry 379
NIH 16
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