Dr Minkowitz has a special interest in clinical research. His major areas of interest are post operative pain management and perioperative control of nausea and vomiting. He has been the principal investigator in a number of research trials and is now in his second decade as a clinical researcher. Listed below are an example of some of his research projects. The Medicines Company, Protocol TMC-CLV-03-01 A prospective, randomized, double blind, placebo-controlled study of clevidipine (CleveloxTM) in the treatment of preoperative hypertension in patients scheduled to undergo cardiac surgery (including coronary artery bypass grafting (CABG), off- pump coronary artery bypass (OPCAB), minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures) Dec. 2003 Escape Ortho-McNeil Pharmaceutical, Inc, Protocol CAPSS-319 Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management after Primary Unilateral Total Hip Replacement, Jan. 2004 Ortho-McNeil Pharmaceutical, Inc, Protocol CAPSS-320 Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management after Non-emergent Lower Abdominal and Pelvic surgery, Feb. 2004 The Medicines Company, Eclipse Protocol TMC-CLV-03-03 A randomized, open label, prospective, parallel group comparison of CleveloxTM (clevidipine) versus nitroglycerin (NTG) for the treatment of hypertension as clinically required perioperatively (the perioperative period comprises the period immediately before surgery, during surgery, and after surgery until discharge from the intensive care unit [ICU] July 2004 Endo Pharmaceuticals Inc., Protocol EN3203-009 Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients with Moderate/Severe Pain Following Abdominal Surgery, September 2004 Daiichi Medical Research, Protocol DU176b-PRT007 A Phase IIa, Multi-Center, Multi-National, Open-Label, Dose Ranging Study of the Efficacy, Safety and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Replacement Arthoplasty, December 2004 GlaxoSmithKline, Protocol NKO101287 A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3mg and 18mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk December 2004 GlaxoSmithKline, Protocol: NKT102260 A Multicenter, Randomized Double-Blind Placebo-controlled, Dose-ranging Parallel Group Phase II Study to Evaluate the Safety Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist GW679769 When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk, March 2005 Hospira, Inc., Protocol 2001-001 A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater than Twenty-Four Hours of Continuous Sedation, May 2005 Merck Research Laboratories, Protocol 015 A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety and Tolerability of IV MK-0517 for the Prevention of Postoperative Nausea and Vomiting (PONV), June 2005 Helsinn Healthcare S.A., Protocol PALO 04-06 A Randomized, Double-blind, Multicenter, Parallel Group, Balanced, Stratified, Phase 3 Study to Evaluate the Efficacy and the Safety of Single IV Doses of Palonosetron 0.025 mg, 0.050 mg, and 0.075 mg versus Placebo in Outpatients to Prevent Post-Operative Nausea and Vomiting Following Elective Abnormal or Gynecological Laparoscopic Surgery July 2005 Organon USA Inc, Protocol 19.4.311 A multicenter, open label, phase IIIa trial to evaluate the efficacy and safety of Org 25969 when used at the end of surgical procedure to reverse the neuromuscular block induced by rocuronium following routine anesthesia, July 2005 Xsira Pharmaceuticals, Protocol ADO-122 A randomized, double-blind, placebo-controlled, escalating dose-response trial of intravenous adenosine for perioperative analgesia in females undergoing abdominal hysterectomy or myomectomy, August 2005 Cadence Pharmaceuticals, Inc., Protocol CPI-266-03 A Phase III, Multi-center, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Administration of Omiganan 1.0% Gel in Preventing Local Catheter Site Infections and Catheter Colonization in Patients Undergoing Central Venous Catheterization September 2005 Thervance, Inc., Protocol 0015 A phase III, Randomized, Double Blind, Parallel Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus, November 2005 Roxro Pharma, Inc. 2005-001 A Phase 3, Double-blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery, December 2005 Pfizer, Protocol A5571010 A Phase 2B, randomized, multi-center, dose-ranging, study assessing the safety and efficacy of PD 0348292 in the prevention of venous thromboembolic events (VTE) in subjects undergoing an elective, unilateral total knee replacement, January 2006 Medgenex, Protocol 055 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study Conducted Under In-House Blinding Conditions to Evaluate the Safety and Efficacy of Oral MK-0686 in the Treatment of Postherpetic Nerualgia, March 2006 DURECT Corporation, Protocol CLIN005-0010 A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Subcutaneous or Subaponeurotic SABER™ Bupivacaine In Patients Undergoing Open Inguinal Hernia Repair, April 2006 DURECT Corporation, Protocol CLIN005-0006 A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Subcutaneous or Subaponeurotic SABER™ Bupivacaine In Patients Undergoing Open Mini-Open Rotator Cuff Repair, May 2006 Organon USA, Inc., Protocol 19.4.303 A multicenter, randomized, parallel group, comparative, active-controlled, safety- assessor blinded, phase IIIa trial in adult subjects comparing recovery from 1.2 mg/kg rocuronium followed by 16 mg/kg Org 25969 at 3 minutes with recovery from 1.0 mg/kg succinylcholine, May 2006 Organon USA, Inc., Protocol 19.4.305 A multicenter, parallel group, comparative, phase IIIa trial to compare the efficacy, safety, and pharmacokinetics of Org 25969 in elderly subjects with adult subjects, May 2006 Javelin Pharmaceuticals, Protocol DFC-004 A randomized, double-blind, active- and placebo-controlled study of the analgesic efficacy and safety of repeated dosing of two dose levels of DIC075V relative to parenteral ketorolac and placebo in patients with acute post-operative pain after abdominal or pelvic surgery, June 2006 Johnson & Johnson, Protocol R331333-PAI-3001 A Randomized, Double-Blind, Active-and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release (IR) Formulation in the Treatment of Acute Pain from Total Hip Replacement followed by a Voluntary Open-Label Extension, July 2006 |
Research Interests.
713 242 3436
Harold S Minkowitz, MD
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