The primary objective is to determine tolerability of ADL 10-0101 in patients with chronic pancreatitis. The second objective is to determine efficacy for pain treatment in this patient group. Although numerous medications can provide pain relief, no single drug, or combination, achieves the ideal. Currently available oral analgesic medications produce undesirable side effects, such as gastrointestinal or renal complications, nausea and sedation, or have limited efficacy. Identification of a new class of analgesic medications with greater efficacy, or fewer side effects, could provide great benefit to mankind. The purpose of this study is to investigate the tolerability and efficacy of a novel drug, ADL 10-0101. ADL 10-0101 was tested in healthy human volunteers and produced analgesic relief. We chose to use this compound first in patients with chronic pancreatitis complicated by moderate to severe pain since this a chronic visceral pain syndrome and is difficult to treat with conventional analgesics.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR007122-09
Application #
6408713
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1992-09-30
Project End
2001-02-28
Budget Start
Budget End
Support Year
9
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
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