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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR ERTAPENEM SODIUM


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505(b)(2) Clinical Trials for ERTAPENEM SODIUM

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 Indication NCT00090272 ↗ 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) Completed Merck Sharp & Dohme Corp. Phase 3 2002-04-01 The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ERTAPENEM SODIUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090272 ↗ 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) Completed Merck Sharp & Dohme Corp. Phase 3 2002-04-01 The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
NCT00092170 ↗ An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038) Completed Merck Sharp & Dohme Corp. Phase 2 2002-03-01 The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.
NCT00379951 ↗ A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048) Completed Merck Sharp & Dohme Corp. Phase 3 2005-06-01 The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
NCT00379964 ↗ A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2005-06-01 The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ERTAPENEM SODIUM

Condition Name

Condition Name for ERTAPENEM SODIUM
Intervention Trials
Urinary Tract Infection 3
Infection 2
Pelvic Infections 1
Colorectal Surgery 1
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Condition MeSH

Condition MeSH for ERTAPENEM SODIUM
Intervention Trials
Communicable Diseases 7
Infections 7
Infection 7
Urinary Tract Infections 3
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Clinical Trial Locations for ERTAPENEM SODIUM

Trials by Country

Trials by Country for ERTAPENEM SODIUM
Location Trials
United States 2
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Trials by US State

Trials by US State for ERTAPENEM SODIUM
Location Trials
Texas 1
New York 1
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Clinical Trial Progress for ERTAPENEM SODIUM

Clinical Trial Phase

Clinical Trial Phase for ERTAPENEM SODIUM
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for ERTAPENEM SODIUM
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 1
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Clinical Trial Sponsors for ERTAPENEM SODIUM

Sponsor Name

Sponsor Name for ERTAPENEM SODIUM
Sponsor Trials
Merck Sharp & Dohme Corp. 11
Albany College of Pharmacy and Health Sciences 1
M.D. Anderson Cancer Center 1
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Sponsor Type

Sponsor Type for ERTAPENEM SODIUM
Sponsor Trials
Industry 11
Other 2
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