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Last Updated: November 29, 2020

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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 Phase 4 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.
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.
NCT00503542 Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network Completed Agency for Healthcare Research and Quality (AHRQ) Phase 0 2007-02-01 Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.
NCT00603616 Induction of Clinical Response Using Rifaximin in Crohn's Disease Recruiting Valeant Pharmaceuticals International, Inc. Phase 2 2008-11-01 Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
NCT00603616 Induction of Clinical Response Using Rifaximin in Crohn's Disease Recruiting Scott Lee Phase 2 2008-11-01 Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
>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 7
Bacterial Vaginosis 2
Crohn's Disease 2
Bacterial Vaginoses 2
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Condition MeSH

Condition MeSH for Flagyl I.v. Rtu In Plastic Container
Intervention Trials
Infection 6
Helicobacter Infections 5
Vaginosis, Bacterial 4
Vaginal Diseases 4
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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 14
India 7
Taiwan 7
Egypt 4
Canada 4
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Trials by US State

Trials by US State for Flagyl I.v. Rtu In Plastic Container
Location Trials
Pennsylvania 3
Michigan 2
North Carolina 1
California 1
Texas 1
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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 15
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Flagyl I.v. Rtu In Plastic Container
Clinical Trial Phase Trials
Completed 14
Not yet recruiting 11
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
Verisfield UK Ltd. Greek Branch 2
Helsinki University Central Hospital 2
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Sponsor Type

Sponsor Type for Flagyl I.v. Rtu In Plastic Container
Sponsor Trials
Other 53
Industry 11
NIH 2
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Serving leading biopharmaceutical companies globally:

Medtronic
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Express Scripts
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AstraZeneca

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