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Therapeutic Areas: Oncology
Disease Category: Cancer Pain
Trial Information
A dose escalation study of NKTR-118 in patients with opioid-induced constipation (OIC).
A Phase 2 study designed to evaluate the safety and efficacy of
NKTR-118 (PEG-naloxol) in patients with opioid-induced
constipation. The objectives of this study are to evaluate the
safety, effectiveness and pharmacokinetics of NKTR-118 at 4
different doses. The study is a multi-center, placebo-controlled,
double-blind, randomized, dose-escalation trial. The study plans to
enroll 224 patients at about 50 sites in the US, Canada and the
EU.
Key Inclusion Criteria:
- 18 years of age or older, male or female
- Receiving a stable opioid regimen
- Documented opioid-induced constipation
- Willingness to stop all laxatives and other bowel regimens. The
use of constipation rescue medication will be allowed during the
study.
Key Exclusion Criteria:
- Life expectancy <6 months
- Active substance abuse
- Fecal incontinence, irritable bowel syndrome, inflammatory
bowel disease, or other active medical disorder associated with
diarrhea or intermittent loose stools or constipation
- Pregnant or breast-feeding
- Any receipt of an investigational medication within 30 days of
screening
- History or presence of specific cardiac, neurologic, endocrine
and/or psychiatric conditions
Carol Weston, Study Coordinator
Tennessee Valley Pain Consultants
927 Franklin St., 2nd Flr.
Huntsville AL 35801
Phone: 256-265-7248 x57248
Fax: 256-265-7017
EMail: carol007@hhsys.org
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