Research Projects & Grants

For Profit Organization

  • A randomized, double-blind, active-controlled crossover study to evaluate the efficacy and safety of fentanyl buccal tablets compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic pain, followed by a 12-week open-label extension to evaluate the impact of fentanyl buccal tablets on patient outcomes (Protocol #C25608/3056/BP/US), Role: PI, Cephalon Inc., (11/2009 - 11/2010) Status: Completed
  • A randomized, double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the treatment of breakthrough cancer pain (INS-05-001), Role: PI, InSys Therapeutics, Inc., (08/2009 - 08/2010) Status: Completed
  • A double blind, randomized, placebo controlled, parallel group dose-range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy, Role: PI, G W Pharmaceuticals, (05/2009 - 05/2010) Status: Completed
  • A multicenter, placebo-controlled, double-blind, two-phase crossover study of Nasalfent (fentanyl citrate nasal spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy (CP043/06/FCNS), Role: PI, Archimedes Development Ltd., (01/2009 - 01/2010) Status: Completed
  • An open-label, two-stage, phase II study to explore the titration schedule for transitioning opioid-experienced patients with non-malignant moderate to severe chronic pain from current opioid therapy to the sufentanil transdermal therapeutic system (#EN3270-201), Role: PI, Endo Pharmaceuticals, (06/2008 - 06/2009) Status: Completed
  • A randomized, double-blind, placebo controlled, crossover study of RWJ-333369 for the treatment of neuropathic pain in diabetic peripheral neuropathy (333369-NPP-2002), Role: PI, Johnson & Johnson, (02/2008 - 02/2009) Status: Completed
  • A randomized, double-blind, placebo-controlled, parallel-group with a crossover confirmation period study of RWJ-333369 for the treatment of postherpetic neuralgia (333369-NNP-2001), Role: PI, Johnson & Johnson, (01/2008 - 01/2009) Status: Completed
  • Multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of lenalidomide in the treatment of complex regional pain syndrome type I, Role: PI, Celgene, Inc., (01/2008 - 01/2009) Status: Completed
  • A randomized double-blind, placebo-controlled, two-way cross over study of analgesic efficacy of bupivacaine transdermal therapeutic system in patients with post-herpetic neuralgia, Role: PI, Durect Corporation, (09/2007 - 09/2008) Status: Completed
  • An open label, long term treatment evaluation of the safety of BEMATM fentanyl use for breakthrough pain in cancer subjects on chronic opioid therapy, Role: PI, BioDelivery Sciences International, Inc., (09/2007 - 09/2008) Status: Completed
  • A double-blind, randomized, placebo-controlled study of modafinil and morphine or oxycodone in patients with excessive daytime sleepiness due to opioid therapy, Role: PI, Medgenex, Inc., (03/2007 - 03/2008) Status: Completed
  • An open-label, long-term safety study to evaluate the safety of the ZR-02-01 Matrix Transdermal Fentanyl patch for the treatment of moderate to severe non-malignant chronic pain., Role: PI, ZARS, Inc., (07/2006 - 07/2007) Status: Completed
  • An open-label, long -term safety study to evaluate the safety of the ZR-02-01 Matrix Transdermal Fentanyl patch for the treatment of moderate to severe cancer pain., Role: PI, ZARS, Inc., (07/2005 - 07/2006) Status: Completed
  • A randomized, double-blinded, placebo-controlled, multicenter phase IIb study to evaluate the efficacy and safety of Multiple Alvimopan dosage regimens for the treatment of Opioid-induced bowel dysfunction in subjects with chronic pain of non-malignant origin, Role: PI, GlaxoSmithKline, (08/2004 - 08/2005) Status: Completed
  • Clinical protocol for a double-blind, placebo controlled comparison of the analgesic efficacy of valdecoxib 20mg, valdecoxib 40mg, oxycodone 10mg/acetaminophen 1000mg and placebo in post-gynecological surgical patients, Role: PI, Searle, (02/2002 - 02/2003) Status: Completed
  • A comparison of the efficacy and safety of topomax tablets versus placebo for the prophylaxis of migraine protocol CAPSS-155 (Protocol issue date: 04 August 2000, Document No: EDMS-USRA-5530809:2.0), Role: PI, Ortho-McNeil Pharmaceutical, (09/2001 - 09/2002) Status: Completed
  • The safety and efficacy of electrotransport E-TRANS (fentanyl HCI) 40 mcg for the treatment of post operative pain: a double blind, multicenter, placebo-controlled trial incorporating JCAHO Pain Management Standards, edition date: June 20, 2001., Role: PI, ALZA Corporation, (09/2001 - 09/2002) Status: Completed
  • An open label evaluation of safety and clinical utility of E-TRANS for management of postoperative pain in children and adolescents. (Protocol C-2000-005-02 dated August 31, 2000), Role: PI, ALZA Corporation, (08/2001 - 08/2002) Status: Completed
  • A randomized, double-blind, placebo-controlled comparison of the analgesic activity of valdecoxib (SC-65872) 40 mg bid as add-on therapy to opoid medication in patients with chronic cancer pain, Role: PI, Searle, (07/2001 - 07/2002) Status: Completed
  • An open label study to evaluate the safety, efficacy, and the conversion strategy from Fentanyl transdermal system to the DUROS sufentanil implant in patients with chronic pain, IND 57641, Role: PI, Durect Corporation, (05/2001 - 05/2002) Status: Completed
  • Clinical protocol for a multicenter, double-blind, randomized study of the efficacy and safety of a single dose of IV parecoxib followed by up to seven days of oral valdecoxib for the pain following laparascopic cholecystectomy, parecoxib IND# 52613, valdecoxib IND #52153, Role: PI, Searle, (02/2001 - 02/2002) Status: Completed
  • A multicenter, multinational, open-label, extension study of oral naloxone for the treatment of opioid-induced constipation in patients with chronic, non-malignant or malignant pain (Protocol: NAL-0597A, FDA IND #22173)., Role: PI, Roxane Laboratories, Inc., (01/2001 - 01/2002) Status: Completed
  • A randomized, double-blind, parallel-design, placebo and active controlled, multicenter, ascending dose-ranging study of the safety and efficacy of single doses of Org 41793 in the treatment of post-operative pain in ASA Class I and II surgical inpatients. (Protocol No. 139-002, dated 08 August 2000), Role: PI, Organon USA Inc., (09/2000 - 09/2001) Status: Completed
  • Clinical Protocol for The Safety and Efficacy o f Electrotransport (E-TRANS) Fentanyl Compared to IV PCA Morphine for the Treatment of Post-Operative Pain, IND # 41,574 (Version August 2, 2000), Role: PI, ALZA Corporation, (08/2000 - 08/2001) Status: Completed
  • Durect Corporation protocol: DUR01-03. A double blind cross-over study to establish conversion ratios between sufentanil and fentanyl followed by an open label phase to determine the efficacy and safety of a continous subcutaneous infusion of sufentannil administered by the DUROS sufentanil implant in patients with chronic pain. (Version date July 14, 2000), Role: PI, Durect Corporation, (08/2000 - 08/2001) Status: Completed
  • An open-label, long-term safety and tolerability study of ziconotide administered intrathecally to patients with chronic, severe pain, IND#: 45,718 (Protocol No. C98-022 including revision 1 and administrative change Nos. 1 and No. 2), Role: PI, NEUREX Division/Elan Pharmaceuticals, Inc., (07/2000 - 07/2001) Status: Completed
  • N91-98-02-033 Clinical protocol for a double-blind, placebo-controlled, single dose comparison of the analgesic activity of SC-65872 40mg, oxycodone 10mg/acetaminophen 1000mg (tylox), and placebo in post general surgical patients, IND #52,153, Role: PI, Searle, (05/2000 - 05/2001) Status: Completed
  • N91-99-02-038 Clinical protocol for a double-blind, placebo controlled comparison of the narcotic sparing activities of valdecoxib 20 mg, valdecoxib 40 mg, and placebo in post-orthopedic surgical patients, IND# 52,153, Role: PI, Scirex, (05/2000 - 05/2001) Status: Completed
  • A phase III, randomized, double-blind, placebo-controlled study to assess the analgesic efficacy and safety of repeated administration of injectable acetaminophen 1 g for the treatment of postoperative pain following orthopaedic surgery (IND# 58,362 and IND# 51,315)., Role: PI, Labboratories UPSA, (05/2000 - 05/2001) Status: Completed
  • Clinical protocol for evaluation of the safety and efficacy of parecoxib 40 mg q 12H followed by valdecoxib 40 mg Q 12H in patients who have coronary artery bypass graft via median sternotomy, Role: PI, G.D. Searle & Co., (02/2000 - 02/2001) Status: Completed
  • An open, randomized, 2-way crossover study comparing the treatment chronic non-malignant pain with duragesic and oxycontin, Role: PI, Janssen Pharmaceutical Products, L.P., (02/2000 - 02/2001) Status: Completed
  • Clinical protocol for a double-blind, placebo-controlled comparison of the analgesic activity of SC-69124A 20 mg IV, SC-69124A 40 mg IV, ketorolac 15 mg IV, morphine 4 mg IV, and placebo in post total hip replacement surgery pateints, IND# 52,613, Role: PI, G.D. Searle & Co., (10/1999 - 10/2000) Status: Completed
  • Open-label dose-titration study of continuous subcutaneous infusion of sufentanil citrate for the treatment of chronic pain, Role: PI, Durect Corporation, (07/1999 - 07/2000) Status: Completed
  • Open-label extension study of continous subcutaneous infusion of sufentanil citrate for the treatment of chronic pain IND# 57,461, Role: PI, Durect Corporation, (07/1999 - 07/2000) Status: Completed
  • A phase III, randomized, double-blind, placebo-controlled study of the analgesic efficacy and safety of single IV administration of 2G propacetamol and 15/30 mg ketorolac for postoperative pain relief after total hip or knee replacement, IND# 51,315, Role: PI, Labboratories UPSA, (10/1998 - 10/1999) Status: Completed
  • A phase III, multi-center, double-blind, randomized, placebo-controlled study of the reversal of opioid-induced gastrointestinal dysfunction in subjects receiving chronic opioid therapy for pain or opioid addiction. [Protocol 13C304 - Version Date as of Amendment 1, April 17, 2001], Role: PI, Adolor Corporation, Status: Completed
  • A multicenter, randomized, double-blind, placebo-controlled,parallel group study to assess the safety and efficacy of GW406381 25 mg and 50 mg, administered once daily for 21 days to subjects with postherpetic neuralgia, Role: PI, GlaxoSmithKline, Status: Completed

Internal

  • A phase II, multi-center, randomized, double-blind, placebo-controlled study of CJC-1008, a long acting, parenteral, opioid analgesic, in the treatment of surgical pain following total knee arthroplasty, IND #60,935. Protocol version: 06/22/01, Role: PI, LLU Dept. of Anesthesiology, (01/2002 - 01/2003) Status: Completed

Non-Profit Organization

  • A study to assess the safety, dose conversion and titration of duragesic in pediatric subjects with chronic pain requiring opioid therapy. FEN-USA-87, Role: PI, Janssen Research Foundation, (09/2001 - 09/2002) Status: Completed