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Last Updated: November 27, 2022

CLINICAL TRIALS PROFILE FOR FLAGYL I.V. RTU IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Flagyl I.v. Rtu 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 Formulation NCT01559545 ↗ A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis Completed Reliance Clinical Research Services (Navi Mumbai, India) Phase 2 2012-03-01 Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation NCT01559545 ↗ A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis Completed Dr. Reddy's Laboratories Limited Phase 2 2012-03-01 Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Flagyl I.v. Rtu In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00195923 ↗ Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis Completed Children's Mercy Hospital Kansas City 2005-04-01 The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.
NCT00257699 ↗ Study of Antibiotics in the Treatment of Colonic Crohn's Disease Terminated Crohn's and Colitis Foundation Phase 2 2006-05-01 Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00257699 ↗ Study of Antibiotics in the Treatment of Colonic Crohn's Disease Terminated Mount Sinai Hospital, Canada Phase 2 2006-05-01 Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00353743 ↗ The Use of Antibiotics After Hospital Discharge in Septic Abortion Terminated Hospital de Clinicas de Porto Alegre N/A 2006-05-01 The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flagyl I.v. Rtu In Plastic Container

Condition Name

Condition Name for Flagyl I.v. Rtu In Plastic Container
Intervention Trials
Helicobacter Pylori Infection 11
Bacterial Vaginosis 6
Crohn's Disease 3
Ulcerative Colitis 2
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Condition MeSH

Condition MeSH for Flagyl I.v. Rtu In Plastic Container
Intervention Trials
Infections 10
Infection 10
Vaginosis, Bacterial 8
Communicable Diseases 8
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Clinical Trial Locations for Flagyl I.v. Rtu In Plastic Container

Trials by Country

Trials by Country for Flagyl I.v. Rtu In Plastic Container
Location Trials
United States 38
Taiwan 10
India 7
Brazil 6
Canada 6
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Trials by US State

Trials by US State for Flagyl I.v. Rtu In Plastic Container
Location Trials
Pennsylvania 4
North Carolina 3
California 3
Texas 3
New York 3
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Clinical Trial Progress for Flagyl I.v. Rtu In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Flagyl I.v. Rtu In Plastic Container
Clinical Trial Phase Trials
Phase 4 25
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Flagyl I.v. Rtu In Plastic Container
Clinical Trial Phase Trials
Completed 36
Unknown status 15
Recruiting 10
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Clinical Trial Sponsors for Flagyl I.v. Rtu In Plastic Container

Sponsor Name

Sponsor Name for Flagyl I.v. Rtu In Plastic Container
Sponsor Trials
National Taiwan University Hospital 4
Chang Gung Memorial Hospital 4
National Institute of Allergy and Infectious Diseases (NIAID) 3
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Sponsor Type

Sponsor Type for Flagyl I.v. Rtu In Plastic Container
Sponsor Trials
Other 98
Industry 19
NIH 5
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