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GT160-246

Phase 2

Clostridium Difficile-Associated Diarrhea | Small molecule | Infectious Disease |Sanofi|Last Updated: Mar 5, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

GT160-246 · 1 trial · 5 indications

Phase 2 1
NCT00034294A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated DiarrheaClostridium Difficile-Associated Diarrhea
COMPLETED300 Analytics
PHASE2COMPLETED
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Clostridium Difficile-Associated DiarrheaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GT160-246DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites99

Inclusion Criteria: * Be at least 18 years old. * Have active mild to moderate C. difficile- Associated Diarrhea (CDAD). * Be able to tolerate oral medication. * Not be pregnant or breast-feeding. * Sign and date an informed consent form.

Countries:United StatesCanadaPuerto RicoUnited Kingdom
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Frequently asked questions about GT160-246

What is GT160-246 used for?

GT160-246 is an investigational small molecule being developed for the treatment of Clostridium difficile-associated diarrhea, a condition also known as Clostridium difficile infection. It is being studied in patients with this infectious disease, which can cause diarrhea and colitis, particularly after antibiotic use.

What does GT160-246 target?

GT160-246 is a small molecule being developed by Sanofi for Clostridium difficile-associated diarrhea. The specific molecular target of GT160-246 has not been disclosed in the available information, so its exact mechanism of action is not detailed here.

Who makes GT160-246?

GT160-246 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this investigational drug for the treatment of Clostridium difficile-associated diarrhea.

What phase is GT160-246 in?

GT160-246 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with Clostridium difficile-associated diarrhea.

What clinical trials is GT160-246 in?

GT160-246 has been studied in one completed Phase 2 clinical trial with the identifier NCT00034294. This randomized, double-blind trial enrolled 300 patients and compared GT160-246 to vancomycin in patients with Clostridium difficile-associated diarrhea. The trial was conducted in the United States, Canada, Puerto Rico, and the United Kingdom.

Is GT160-246 the same as vancomycin?

No, GT160-246 is not the same as vancomycin. GT160-246 is an investigational small molecule being developed by Sanofi, while vancomycin is an established antibiotic used as a comparator in the clinical trial. The Phase 2 study evaluated GT160-246 against vancomycin in patients with Clostridium difficile-associated diarrhea.