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Last Updated: February 26, 2021

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CLINICAL TRIALS PROFILE FOR METRONIDAZOLE

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505(b)(2) Clinical Trials for Metronidazole

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

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.
NCT00021671 Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission Completed National Institute of Mental Health (NIMH) Phase 3 1969-12-31 The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metronidazole

Condition Name

Condition Name for Metronidazole
Intervention Trials
Helicobacter Pylori Infection 61
Bacterial Vaginosis 35
Chronic Periodontitis 12
Periodontitis 10
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Condition MeSH

Condition MeSH for Metronidazole
Intervention Trials
Infection 87
Helicobacter Infections 71
Communicable Diseases 64
Vaginosis, Bacterial 47
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Clinical Trial Locations for Metronidazole

Trials by Country

Trials by Country for Metronidazole
Location Trials
United States 433
Taiwan 37
Canada 35
China 31
India 23
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Trials by US State

Trials by US State for Metronidazole
Location Trials
Texas 30
California 28
Pennsylvania 24
North Carolina 22
Florida 20
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Clinical Trial Progress for Metronidazole

Clinical Trial Phase

Clinical Trial Phase for Metronidazole
Clinical Trial Phase Trials
Phase 4 151
Phase 3 79
Phase 2/Phase 3 17
[disabled in preview] 64
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Clinical Trial Status

Clinical Trial Status for Metronidazole
Clinical Trial Phase Trials
Completed 170
Recruiting 102
Not yet recruiting 74
[disabled in preview] 47
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Clinical Trial Sponsors for Metronidazole

Sponsor Name

Sponsor Name for Metronidazole
Sponsor Trials
National Taiwan University Hospital 18
National Institute of Allergy and Infectious Diseases (NIAID) 12
Shanghai Jiao Tong University School of Medicine 11
[disabled in preview] 12
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Sponsor Type

Sponsor Type for Metronidazole
Sponsor Trials
Other 484
Industry 119
NIH 21
[disabled in preview] 10
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