You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR METRONIDAZOLE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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 1995-08-10 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.
>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 83
Bacterial Vaginosis 42
Chronic Periodontitis 12
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for metronidazole hydrochloride
Intervention Trials
Infections 115
Infection 98
Helicobacter Infections 83
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for metronidazole hydrochloride

Trials by Country

Trials by Country for metronidazole hydrochloride
Location Trials
United States 535
China 78
Taiwan 43
Canada 38
Japan 38
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for metronidazole hydrochloride
Location Trials
California 38
Texas 34
North Carolina 26
Florida 24
Ohio 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for metronidazole hydrochloride

Clinical Trial Phase

Clinical Trial Phase for metronidazole hydrochloride
Clinical Trial Phase Trials
Phase 4 191
Phase 3 90
Phase 2/Phase 3 24
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for metronidazole hydrochloride
Clinical Trial Phase Trials
Completed 265
Unknown status 77
Recruiting 68
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for metronidazole hydrochloride

Sponsor Name

Sponsor Name for metronidazole hydrochloride
Sponsor Trials
National Taiwan University Hospital 19
Shanghai Jiao Tong University School of Medicine 16
Pfizer 14
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for metronidazole hydrochloride
Sponsor Trials
Other 651
Industry 163
NIH 23
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.