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Last Updated: July 8, 2020

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CLINICAL TRIALS PROFILE FOR FLAGYL

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505(b)(2) Clinical Trials for Flagyl

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 Flagyl

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00195923 Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis Completed Children's Mercy Hospital Kansas City Phase 4 2005-04-01 The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.
NCT00353743 The Use of Antibiotics After Hospital Discharge in Septic Abortion Terminated Hospital de Clinicas de Porto Alegre N/A 2006-05-01 The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
NCT00503542 Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network Completed Agency for Healthcare Research and Quality (AHRQ) Phase 0 2007-02-01 Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.
NCT00603616 Induction of Clinical Response Using Rifaximin in Crohn's Disease Recruiting Valeant Pharmaceuticals International, Inc. Phase 2 2008-11-01 Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
NCT00603616 Induction of Clinical Response Using Rifaximin in Crohn's Disease Recruiting Scott Lee Phase 2 2008-11-01 Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
NCT01032655 The Efficacy of Susceptibility Test -Driven Sequential Therapy as the Third Line Therapy for Refractory Helicobacter Pylori Infection Completed National Taiwan University Hospital Phase 4 2009-04-01 Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. The commonly used salvage regimens include (1) Bismuth based quadruple therapy (combined with ranitidine or PPI plus two antibiotics) (2) Levofloxacin or moxifloxacin or rifabutin based triple therapy. However, Bismuth is not available in many countries and the administration method is complex. Its usage is limited by the high pill number and low compliance rate. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. According to the Maastricht III consensus meeting, it was recommended that susceptibility test should be done for patients who failed two treatments. Therefore, we aimed to assess the efficacy of susceptibility test driven sequential therapy as the third line therapy for those who fail from two standard eradication therapies. Methods: This will be a multi-center, open labeled pilot study 1. Patients: - Open labeled, non-comparative pilot study 2. Testing for H. pylori infection: - Before salvage treatment: either (1) any two positive of CLO test, histology, and culture or (2) a positive C13-UBT will be considered as failure of previous eradication treatment EGD with gastric biopsy will be done for H. pylori culture and susceptibility test - After salvage treatment: C13-UBT will be used to assess the existence of H. pylori after 2nd or 3rd line salvage therapy 3. Treatment regimens and assignment: - D1-7: Nexium (40 mg, bid), Amolin (1 gm, bid) - D8-14: Nexium (40 mg, bid), Flagyl (500 mg, bid) plus either one of the following according to antibiotic susceptibility test (1) Klaricid, 500 mg, bid or (2) Cravit, 250 mg, bid or (3) Tetracycline, 500 mg, bid 4. Outcome Measurement: - Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses - Secondary End Point: the eradication rate according to antibiotic susceptibility before salvage therapy
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flagyl

Condition Name

Condition Name for Flagyl
Intervention Trials
Helicobacter Pylori Infection 5
Bacterial Vaginosis 2
Crohn's Disease 2
Bacterial Vaginoses 2
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Condition MeSH

Condition MeSH for Flagyl
Intervention Trials
Infection 6
Helicobacter Infections 5
Vaginosis, Bacterial 4
Vaginal Diseases 4
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Clinical Trial Locations for Flagyl

Trials by Country

Trials by Country for Flagyl
Location Trials
United States 14
India 7
Taiwan 6
Canada 4
Brazil 3
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Trials by US State

Trials by US State for Flagyl
Location Trials
Pennsylvania 3
Michigan 2
North Carolina 1
California 1
Texas 1
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Clinical Trial Progress for Flagyl

Clinical Trial Phase

Clinical Trial Phase for Flagyl
Clinical Trial Phase Trials
Phase 4 13
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Flagyl
Clinical Trial Phase Trials
Completed 14
Not yet recruiting 10
Recruiting 9
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Clinical Trial Sponsors for Flagyl

Sponsor Name

Sponsor Name for Flagyl
Sponsor Trials
National Taiwan University Hospital 4
Verisfield UK Ltd. Greek Branch 2
Helsinki University Central Hospital 2
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Sponsor Type

Sponsor Type for Flagyl
Sponsor Trials
Other 50
Industry 11
NIH 2
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