An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Condition(s) targeted: Pain, Postoperative

Intervention: DIC075V (intravenous diclofenac sodium) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Javelin Pharmaceuticals

Official(s) and/or principal investigator(s):
Javelin Pharmaceuticals, Study Director, Affiliation: Javelin Pharmaceuticals

Overall contact:
Javelin Pharmaceuticals, Email: clinicaltrials@javelinpharma.com

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

Official title: An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Study design: Treatment, Open Label, Active Control, Single Group Assignment, Safety Study

Primary outcome: Adverse Events

Detailed description: This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i. e., non-laparoscopic abdominal surgeries) or orthopedic (e. g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint

replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days

- Expected stay > 48 hrs

Exclusion Criteria:

- bilirubin > 2. 5 mg/dl

- prothrombin time is > 20% above the upper limit of normal

- serum creatinine is > 1. 9 mg/dl at screening.

- known allergy or hypersensitivity to diclofenac, other NSAIDs,

Javelin Pharmaceuticals, Email: clinicaltrials@javelinpharma.com

Jefferson Clinic, Birmingham, Alabama 35233, United States; Recruiting
Linda Mott, Phone: 205-521-6207, Email: lmott@jeffersonclinic.com
Rowell Ashford, Principal Investigator

Jackson Hospital, Montgomery, Alabama 36106, United States; Recruiting
Wrenn McGhee, LPN, Phone: 334-265-2700
Christopher Duggar, Principal Investigator

Drug Research and Analysis Corp., Montgomery, Alabama 36106, United States; Recruiting
Wrenn McGhee, Phone: 334-265-2700
John Frazer, Principal Investigator

Helen Keller Memorial Hospital, Sheffield, Alabama 35660, United States; Recruiting
Peg Pennington, Phone: 256-386-4001, Email: ppenn35633@yahoo.com
Timoty Melson, Principal Investigator

Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States; Recruiting
Lisa Palmedo, Phone: 205-833-2228
Ron Savage, Principal Investigator

Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital, Florence, Alabama 35630, United States; Recruiting
Sharon Bratcher, Phone: 256-768-8021
Alvaro Segura-vasi, Principal Investigator

Horizon Research Group, Mobile, Alabama 36608, United States; Recruiting
Email: lhess@horizonresearch.us
Roger Setzler, Principal Investigator

Pivitol Research, Mesa, Arizona 85210, United States; Recruiting
Michele Aguirre, Phone: 480-615-3200
Richard Carlson, Principal Investigator

PACT, Phoenix, Arizona 85006, United States; Recruiting
Solia Carlos, Phone: 602-258-4951
Marc Gotfried, Principal Investigator

Pivotal Clinical Research, Peoria, Arizona 85381, United States; Recruiting
Joanne Mashburn, Phone: 623-815-9714
Robert Rankel, Principal Investigator

Teton Research, LLC, Little Rock, Arkansas 72205, United States; Recruiting
Cara Atkinson, Phone: 501-975-8989
Kenneth Martin, Principal Investigator

Lotus Clinical Research, Pasadena, California 91105, United States; Recruiting
Kim Sheng, Phone: 626-397-2383, Email: kim@lotuscr.com
Vaibhavi Madhu Anvekar, Principal Investigator

North Coast Women's Care, Vista, California 92083, United States; Recruiting
Mary Fenton
Christine Brody, Principal Investigator

California Clinical Research, Davis, California 95616, United States; Recruiting
Martha Daschbach, Phone: 530-848-8106
Thomas Hughes, Principal Investigator

University of California Ronald Regan Medical Center, Los Angeles, California 90095, United States; Recruiting
Nadia Basharkhah, Email: nbasharkhah@mednet.ucla.edu
Jonathan Jahr, Principal Investigator

National Institute of Research, Los Angeles, California, United States; Recruiting
Vinny Huynh, Phone: 213-481-2568
Gali Khetan, Principal Investigator

Physicians Clinical Research, Laguna HIlls, California 92653, United States; Recruiting
Amber Degelia, Phone: 949-699-4190
Arthur Levine, Principal Investigator

National Institute of Clinical Research, Los Angeles, California 90017, United States; Recruiting
Shiblee Nomanee, Phone: 213-481-2568
Robert Naraghi, Principal Investigator

CORE Orthopaedic Medical Center, Encinitas, California 92024, United States; Recruiting
Farouk Awad, Phone: 760-943-6710, Ext: 162
Timothy Peppers, Principal Investigator

Colorado Orthopedic Consultants, Englewood, Colorado 80110, United States; Recruiting
Shane Lieberman, Phone: 303-695-6060, Ext: 262
John Schwappach, Principal Investigator

Orthopedic Associates of Hartford, Hartford, Connecticut, United States; Recruiting
Stephanie Caminiti, Phone: 860-549-8977
Cortland Lewis, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Luis Mujica, Phone: 305-585-7677
Keith Candiotti, Principal Investigator

Florida Orthopedic Institute, Tampa, Florida 33637, United States; Recruiting
Paula Hall, Phone: 813-978-9700, Ext: 7348
Kenneth Gustke, Principal Investigator

Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States; Recruiting
Ivette Arosemena, Phone: 954-958-4800
Martin Roche, Principal Investigator

Atlanta Colon & Rectal Surgery, Atlanta, Georgia 30342, United States; Recruiting
Mitzi Roberts, Phone: 678-354-9252
Sander Binderow, Principal Investigator

Southeastern Center for Clinical Trials, Atlanta, Georgia 30350, United States; Recruiting
George Rainey, Phone: 404-297-1997
Maurice Jove, Principal Investigator

Soapstone Center for Clinical Research, Decatur, Georgia 33034, United States; Recruiting
Email: soapstone_research@hotmail.com
Tyrone Malloy, Principal Investigator

JRSI Foundation The center for Hip and Knee Surgery, Mooresville, Indiana 46158, United States; Recruiting
Amy Robertson, Phone: 317-834-5138, Email: arobertsonrn@yahoo.com
Michael Berend, Principal Investigator

Indiana University School of Medicine, Dept of Anesthesia, Indianapolis, Indiana 46202, United States; Recruiting
Kathy Arney, Phone: 317-274-0265
John Butterworth, Principal Investigator

VAMC Pain, Indianapolis, Indiana 46202, United States; Recruiting
Kathy Arney, Phone: 317-274-0265
Ahamed Elsahy, Principal Investigator

University of Kansas Medical Center Department of Anesthesiology, Kansas City, Kansas 66160, United States; Recruiting
Kristy Nichols, Phone: 913-588-4583
Anthony Kovac, Principal Investigator

Validity Research, Merriam, Kansas 66204, United States; Recruiting
Jay Langness, Phone: 919-543-3599
Jeffrey MacMiillian, Principal Investigator

Tulane Univ. Medical Center, New Orleans, Louisiana 70113, United States; Recruiting
Nathalie Medeiros, Phone: 504-988-5068
Frank Rosinia, Principal Investigator

Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States; Recruiting
Michael Mont, Principal Investigator

Great Falls Clinic, LLP, Great Falls, Montana 59405, United States; Recruiting
Connie Winner, Phone: 406-268-3920
Nicholas Bonfilio, Principal Investigator

Cooper University Hospital, Camden, New Jersey, United States; Recruiting
Robin Tarpley, Email: tarpley-robyn@cooperheatlth.edu
Ronak Desai, Principal Investigator

Rothman Institute, Egg Harbor Township, New Jersey, United States; Recruiting
Jamie Blair, Phone: 609-677-7015
Alvin Ong, Principal Investigator

Albany Medical Center, Albany, New York 12208, United States; Recruiting
Michelle Martin, Phone: 518-262-3314
Scott Groudine, Principal Investigator

Staten Island University Hospital, Staten Island, New York 10305, United States; Recruiting
Elysha Grauman, Phone: 718-226-1026
Barry Hahn, Principal Investigator

Mount Sinai School of Medicine -BRANY, New York, New York 10029, United States; Recruiting
Dionne Bobb, Phone: 212-241-7749
Hatim Hyderally, Principal Investigator

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
John Darnell, Phone: 336-735-6181, Ext: 120
Chris Gilmore, Principal Investigator

The Ohio State University Medical Center, Columbus, Ohio 43210, United States; Recruiting
Kelly Rosborough, Phone: 614-293-3559, Email: kelly.rosborough@osumc.edu
Sergio Bergese, Principal Investigator

Ilumina Clinical Associates, Johnstown, Pennsylvania 15504, United States; Recruiting
Sharon Staron, Phone: 814-467-4490
David Bizousky, Principal Investigator

UPMC Presbyterian-Shadyshide Hospital, Pittsburg, Pennsylvania 15232, United States; Recruiting
Dawn M Tucker, Phone: 412-623-4147
Jacques Chelly, Principal Investigator

Allegheny Pain Management, Altoona, Pennsylvania 16602, United States; Recruiting
Lori Letcher, Phone: 814-940-2000, Ext: 600
Michael Drass, Principal Investigator

Magee-Women's Hospital, Pittsburg, Pennsylvania 15213, United States; Recruiting
Amy Albright, Phone: 412-641-4154
Bupush Kaul, Principal Investigator

Sewickley Valley Hospital, Sewickley, Pennsylvania 15143, United States; Recruiting
Katie Keller, Phone: 412-749-7193
John Koncelik, Principal Investigator

Ilumina Clinical Associates, Johnstown, Pennsylvania 15904, United States; Recruiting
Mary Temple, Phone: 724-646-0400
Daryl List, Principal Investigator

UPMC-St. Margaret's Hospital, Pittsburg, Pennsylvania 15232, United States; Recruiting
Rose Lanzo, Phone: 412-623-2706
Charles Richards, Principal Investigator

University Orthopedics Center, State College, Pennsylvania 16801, United States; Recruiting
Sue Jepson, Phone: 814-231-2101
Edwin Rogusky, Principal Investigator

Somerset Hospital, Somerset, Pennsylvania 15501, United States; Recruiting
Gwen Berardinelli, Phone: 814-467-4490
Gary Schmidt, Principal Investigator

Comprehensive Pain Specialists, PLLC, Hendersonville, Tennessee 37075, United States; Recruiting
Laura Meadows, Phone: 615-305-3700
Peter Kroll, Principal Investigator

Interventional Pain Management, San Antonio, Texas 78258, United States; Recruiting
Reema, Phone: 210-259-3113, Email: reema@luminantresearch.com
Urfan Dar, Principal Investigator

Hill Country Clinical Research, Austin, Texas 78759, United States; Recruiting
Melissa Gattis, Phone: 512-638-3242
Marc Dehart, Principal Investigator

Scott & White Clinic / Texas A&M Health Science Center, Temple, Texas 76508, United States; Recruiting
Tiffany Mendoza, Phone: 254-724-5566
David Gloyna, Principal Investigator

Endeavor Clinical Trials, San Antonio, Texas 78229, United States; Recruiting
Andrea Pena, Phone: 210-949-0807
Joe Johnston, Principal Investigator

Baylor Research Institute at Baylor All Saints Medical Center, Fort Worth, Texas 76104, United States; Recruiting
Kate Newman, Phone: 214-820-3296
Michael Ramsay, Principal Investigator

Endeavor Clinical Trials, San Antonio, Texas 78229, United States; Recruiting
Diana Strange, Phone: 210-949-0807
David Schmidt, Principal Investigator

Starting date: September 2008
Ending date: July 2009
Last updated: February 11, 2009