A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

PHASE2CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

April 30, 2009

Conditions
Opioid Induced Constipation (OIC)
Interventions
DRUG

placebo

placebo, oral, once daily (QD)

DRUG

NKTR-118

5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Trial Locations (33)

11023

Long Island Gastrointestinal Research Group, Great Neck

21075

Centennial Medical Group, Elkridge

27103

The Center for Clinical Research, LLC, Winston-Salem

28731

Four Seasons Hospice and Palliative Care, Flat Rock

29118

Singleton Health Center, Orangeburg

29621

Anderson Gastroenterology Associates, LLC, Anderson

30312

PMI Health Research Group, Atlanta

32626

Southeast Clinical Research, Chiefland

32901

Osler Medical, Inc. / Osler Clinical Research, Melbourne

33324

Gold Coast Research LLC, Weston

33409

Palm Beach Research Center, West Palm Beach

35126

Deerfoot Internal Medicine, Pinson

35801

Tennessee Valley Pain Consultants / Center for Pain Management, Huntsville

37421

ClinSearch, LLC, Chattanooga

40503

Pain Treatment Center of the Bluegrass, Lexington

44718

Gabrail Cancer Center, Canton

45219

Riverhills Healthcare Research Division, Cincinnati

46254

Investigative Clinical Research of Indiana, LLC, Indianapolis

55435

MAPS Applied Research Center, Edina

60610

Pain & Rehabilitation Clinic of Chicago, Chicago

61701

Millennium Pain Center, Bloomington

63376

Midwest Pharmaceutical Research, Inc., City of Saint Peters

70808

Gulf Coast Reserach, Baton Rouge

74104

Options Health Research, Tulsa

80120

Arapahoe Gastroenterology, PC, Littleton

83704

Northwest Clinical Trials, Boise

84106

Lifetree Clinical Research, Salt Lake City

85741

Genova Clinical Research, Inc., Tucson

87108

Lovelace Scientific Resources, Inc., Albuquerque

92128

San Diego Managed Care Group, San Diego

92653

Therapeutic Research Institute of Orange County, Laguna Hills

97504

Medford Medical Clinic, Medford

99216

Spokane Internal Medicine, Spokane

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nektar Therapeutics

INDUSTRY

lead

AstraZeneca

INDUSTRY