Trials / Completed
CompletedNCT00090272
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)
A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 952 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The duration of treatment is 1 day.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK0826, ertapenem sodium | |
| DRUG | Comparator: cefotetan |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2005-03-01
- Completion
- 2005-03-01
- First posted
- 2004-08-27
- Last updated
- 2017-02-17
Source: ClinicalTrials.gov record NCT00090272. Inclusion in this directory is not an endorsement.