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MK0826, ertapenem

Phase 3

Colorectal Surgery | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: Feb 17, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment952

FDA Designations

No designations recorded

Clinical trial landscape

MK0826, ertapenem · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00090272A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)Colorectal Surgery
COMPLETED952 Analytics
PHASE3COMPLETED
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)
Colorectal SurgeryUnlock trial analytics

Study Endpoints

Primary Endpoints

Surgical site infection following elective colorectal surgery based on surgical site assessment.
Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy

Secondary Endpoints

Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
MK0826, ertapenem sodiumDRUG -
Comparator: cefotetanDRUG -
Comparator: Ticarcillin/ClavulanateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria: * Surgery must be scheduled in advance. * There must be adequate time to complete preoperative bowel preparation

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Frequently asked questions about MK0826, ertapenem

What is MK0826 (ertapenem) used for?

MK0826, also known as ertapenem, is an investigational small molecule being studied for the treatment of colorectal surgery infections, complicated intra-abdominal infections, and intra-abdominal infections. It is in Phase 3 clinical development for these gastrointestinal indications.

What does MK0826 (ertapenem) target?

MK0826, also known as ertapenem, is a carbapenem antibiotic that targets bacterial cell wall synthesis. It is being studied for its effectiveness against infections following colorectal surgery and complicated intra-abdominal infections.

Who makes MK0826 (ertapenem)?

MK0826, also known as ertapenem, is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug for the treatment of intra-abdominal infections.

What phase is MK0826 (ertapenem) in?

MK0826, also known as ertapenem, is in Phase 3 clinical development. It is an investigational drug and has not been approved for the indications being studied, including colorectal surgery infections and complicated intra-abdominal infections.

What clinical trials is MK0826 (ertapenem) in?

MK0826, also known as ertapenem, has completed several clinical trials. These include NCT00090272, a Phase 3 study in colorectal surgery with 952 participants, and NCT00389987, a Phase 3 study in complicated intra-abdominal infections with 300 participants.

Is MK0826 the same as ertapenem?

Yes, MK0826 is the same as ertapenem. The drug is referred to by both names in clinical trials, including studies NCT00090272 and NCT00389987, which evaluate ertapenem for the treatment of intra-abdominal infections.