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Sponsors and Collaborators: |
University of Rochester Endo Pharmaceuticals EKR Therapeutics, Inc |
Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00335517 |
The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
Condition | Intervention |
Lumbar Spine Surgery |
Drug: DepoDur |
ChemIDplus related topics: | S 1 (Combination) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant or are not practicing medically acceptable contraception (a pregnancy test is used pre-operatively as part of standard of care).
Patients who experience complications during the surgery (e.g., major hemorrhage, dural puncture) will not receive the study drug.
Contact: Glenn Rechtine, MD | 585-275-8780 | glenn_rechtine@urmc.rochester.edu |
United States, New York | |||||
University of Rochester Medical Center | Recruiting | ||||
Rochester, New York, United States, 14642 | |||||
Contact: Glenn Rechtine, MA glenn_rechtine@urmc.rochester.edu | |||||
Principal Investigator: Glenn Rechtine, MD | |||||
Sub-Investigator: Paul T Rubery, MD | |||||
Sub-Investigator: Robert Molinari, MD | |||||
Sub-Investigator: Seth Zeidman, MD |
University of Rochester |
Endo Pharmaceuticals |
EKR Therapeutics, Inc |
Principal Investigator: | Rechtine Glenn, MD | University of Rochester |
Responsible Party: | University of Rochester ( Glenn Rechtine, MD ) |
Study ID Numbers: | 11678 |
First Received: | June 8, 2006 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00335517 |
Health Authority: | United States: Institutional Review Board |
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