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Last Updated: January 19, 2020

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CLINICAL TRIALS PROFILE FOR METRONIDAZOLE HYDROCHLORIDE

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

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 Metronidazole Hydrochloride

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.
NCT00003151 Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma Completed European Organisation for Research and Treatment of Cancer - EORTC 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metronidazole Hydrochloride

Condition Name

Condition Name for Metronidazole Hydrochloride
Intervention Trials
Helicobacter Pylori Infection 52
Bacterial Vaginosis 35
Chronic Periodontitis 12
Periodontitis 9
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Condition MeSH

Condition MeSH for Metronidazole Hydrochloride
Intervention Trials
Infection 82
Helicobacter Infections 67
Communicable Diseases 60
Vaginosis, Bacterial 46
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Clinical Trial Locations for Metronidazole Hydrochloride

Trials by Country

Trials by Country for Metronidazole Hydrochloride
Location Trials
United States 430
Taiwan 35
Canada 35
China 27
India 23
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Trials by US State

Trials by US State for Metronidazole Hydrochloride
Location Trials
Texas 29
California 28
Pennsylvania 24
North Carolina 22
Florida 20
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Clinical Trial Progress for Metronidazole Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Metronidazole Hydrochloride
Clinical Trial Phase Trials
Phase 4 138
Phase 3 75
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Metronidazole Hydrochloride
Clinical Trial Phase Trials
Completed 164
Recruiting 95
Not yet recruiting 58
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Clinical Trial Sponsors for Metronidazole Hydrochloride

Sponsor Name

Sponsor Name for Metronidazole Hydrochloride
Sponsor Trials
National Taiwan University Hospital 16
National Institute of Allergy and Infectious Diseases (NIAID) 12
Shanghai Jiao Tong University School of Medicine 8
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Sponsor Type

Sponsor Type for Metronidazole Hydrochloride
Sponsor Trials
Other 444
Industry 117
NIH 20
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