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Last Updated: May 12, 2021

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CLINICAL TRIALS PROFILE FOR FLAGYL I.V.

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505(b)(2) Clinical Trials for Flagyl I.v.

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.

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flagyl I.v.

Condition Name

Condition Name for Flagyl I.v.
Intervention Trials
Helicobacter Pylori Infection 7
Bacterial Vaginosis 2
Vaginal Discharge 2
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Condition MeSH

Condition MeSH for Flagyl I.v.
Intervention Trials
Infection 6
Helicobacter Infections 5
Vaginal Diseases 4
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Clinical Trial Locations for Flagyl I.v.

Trials by Country

Trials by Country for Flagyl I.v.
Location Trials
United States 15
Taiwan 7
India 7
Egypt 4
Canada 4
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Trials by US State

Trials by US State for Flagyl I.v.
Location Trials
Pennsylvania 3
Michigan 2
Texas 2
Virginia 1
Washington 1
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Clinical Trial Progress for Flagyl I.v.

Clinical Trial Phase

Clinical Trial Phase for Flagyl I.v.
Clinical Trial Phase Trials
Phase 4 16
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Flagyl I.v.
Clinical Trial Phase Trials
Not yet recruiting 14
Completed 14
Recruiting 10
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Clinical Trial Sponsors for Flagyl I.v.

Sponsor Name

Sponsor Name for Flagyl I.v.
Sponsor Trials
National Taiwan University Hospital 4
National Institute of Allergy and Infectious Diseases (NIAID) 2
Par Pharmaceutical, Inc. 2
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Sponsor Type

Sponsor Type for Flagyl I.v.
Sponsor Trials
Other 56
Industry 11
NIH 3
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