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