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A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Opioid Induced Constipation (OIC)

Thank you

Trial Information

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)


Main

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.

Main Exclusion Criteria:

- Life expectancy less than 6 months

- Active substance abuse

- Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other
active medical disorders 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Increase in number of spontaneous bowel movements from baseline

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

Mark Sostek

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca Pharmaceuticals, Wilm DE

Authority:

United States: Food and Drug Administration

Study ID:

07-IN-NX003

NCT ID:

NCT00600119

Start Date:

December 2007

Completion Date:

April 2009

Related Keywords:

  • Opioid Induced Constipation (OIC)
  • NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
  • Constipation

Name

Location

Gabrail Cancer CenterCanton, Ohio  44718
Palm Beach Research CenterWest Palm Beach, Florida  33409
Lifetree Clinical ResearchSalt Lake City, Utah  84106
The Center for Clinical Research, LLCWinston-Salem, North Carolina  27103
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Millennium Pain CenterBloomington, Illinois  61701
Options Health ResearchTulsa, Oklahoma  74104
Anderson Gastroenterology Associates, LLCAnderson, South Carolina  39621
Therapeutic Research Institute of Orange CountyLaguna Hills, California  92653
Tennessee Valley Pain Consultants / Center for Pain ManagementHuntsville, Alabama  35801
Deerfoot Internal MedicinePinson, Alabama  35126
Genova Clinical Research, Inc.Tucson, Arizona  85741
San Diego Managed Care GroupSan Diego, California  92128
Arapahoe Gastroenterology, PCLittleton, Colorado  80120
Southeast Clinical ResearchChiefland, Florida  32626
Osler Medical, Inc. / Osler Clinical ResearchMelbourne, Florida  32901
Gold Coast Research LLCWeston, Florida  33324
PMI Health Research GroupAtlanta, Georgia  30312
Northwest Clinical TrialsBoise, Idaho  83704
Pain & Rehabilitation Clinic of ChicagoChicago, Illinois  60610
Pain Treatment Center of the BluegrassLexington, Kentucky  40503
Gulf Coast ReserachBaton Rouge, Louisiana  70808
Centennial Medical GroupElkridge, Maryland  21075
MAPS Applied Research CenterEdina, Minnesota  55435
Midwest Pharmaceutical Research, Inc.St. Peters, Missouri  63376
Lovelace Scientific Resources, Inc.Albuquerque, New Mexico  87108
Long Island Gastrointestinal Research GroupGreat Neck, New York  11023
Four Seasons Hospice and Palliative CareFlat Rock, North Carolina  28731
Riverhills Healthcare Research DivisionCincinnati, Ohio  45219
Medford Medical ClinicMedford, Oregon  97504
Singleton Health CenterOrangeburg, South Carolina  29118
ClinSearch, LLCChattanooga, Tennessee  37421
Spokane Internal MedicineSpokane, Washington  99216