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CLINICAL TRIALS PROFILE FOR METRONIDAZOLE IN PLASTIC CONTAINER

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505(b)(2) Clinical Trials for Metronidazole 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.

All Clinical Trials for Metronidazole In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002682	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-01	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-01	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.

Clinical Trial Conditions for Metronidazole In Plastic Container

Condition Name

Condition Name for Metronidazole In Plastic Container
Intervention	Trials
Helicobacter Pylori Infection	61
Bacterial Vaginosis	36
Chronic Periodontitis	12

Condition MeSH

Condition MeSH for Metronidazole In Plastic Container
Intervention	Trials
Infection	87
Helicobacter Infections	71
Communicable Diseases	64

Clinical Trial Locations for Metronidazole In Plastic Container

Trials by Country

Trials by Country for Metronidazole In Plastic Container
Location	Trials
United States	433
Taiwan	37
Canada	35
China	32
India	23

Trials by US State

Trials by US State for Metronidazole In Plastic Container
Location	Trials
Texas	30
California	28
Pennsylvania	24
North Carolina	22
Ohio	20

Clinical Trial Progress for Metronidazole In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Metronidazole In Plastic Container
Clinical Trial Phase	Trials
Phase 4	154
Phase 3	79
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Metronidazole In Plastic Container
Clinical Trial Phase	Trials
Completed	171
Recruiting	103
Not yet recruiting	75

Clinical Trial Sponsors for Metronidazole In Plastic Container

Sponsor Name

Sponsor Name for Metronidazole In Plastic Container
Sponsor	Trials
National Taiwan University Hospital	18
National Institute of Allergy and Infectious Diseases (NIAID)	12
Shanghai Jiao Tong University School of Medicine	11

Sponsor Type

Sponsor Type for Metronidazole In Plastic Container
Sponsor	Trials
Other	487
Industry	120
NIH	21