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