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Last Updated: October 7, 2024

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 1995-08-10 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 1995-08-10 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 87
Bacterial Vaginosis 43
Periodontitis 13
Chronic Periodontitis 12
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Condition MeSH

Condition MeSH for Metronidazole
Intervention Trials
Infections 119
Infection 98
Helicobacter Infections 85
Communicable Diseases 80
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Clinical Trial Locations for Metronidazole

Trials by Country

Trials by Country for Metronidazole
Location Trials
United States 538
China 78
Taiwan 43
Canada 38
Japan 38
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Trials by US State

Trials by US State for Metronidazole
Location Trials
California 38
Texas 34
North Carolina 26
Ohio 24
Florida 24
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Clinical Trial Progress for Metronidazole

Clinical Trial Phase

Clinical Trial Phase for Metronidazole
Clinical Trial Phase Trials
Phase 4 196
Phase 3 92
Phase 2/Phase 3 24
[disabled in preview] 77
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Clinical Trial Status

Clinical Trial Status for Metronidazole
Clinical Trial Phase Trials
Completed 268
Unknown status 77
Recruiting 75
[disabled in preview] 72
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Clinical Trial Sponsors for Metronidazole

Sponsor Name

Sponsor Name for Metronidazole
Sponsor Trials
National Taiwan University Hospital 19
Shanghai Jiao Tong University School of Medicine 16
Pfizer 14
[disabled in preview] 20
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Sponsor Type

Sponsor Type for Metronidazole
Sponsor Trials
Other 670
Industry 163
NIH 24
[disabled in preview] 15
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