A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
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)
1 other identifier
interventional
207
1 country
33
Brief Summary
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Shorter than P25 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
June 12, 2015
CompletedJune 12, 2015
May 1, 2015
1.2 years
January 11, 2008
October 13, 2014
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
Days 1 through 7
Secondary Outcomes (3)
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Days 1 through 28
Study Arms (2)
A
PLACEBO COMPARATORPlacebo
B
EXPERIMENTALNKTR-118
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Nektar Therapeuticscollaborator
Study Sites (33)
Tennessee Valley Pain Consultants / Center for Pain Management
Huntsville, Alabama, 35801, United States
Deerfoot Internal Medicine
Pinson, Alabama, 35126, United States
Genova Clinical Research, Inc.
Tucson, Arizona, 85741, United States
Therapeutic Research Institute of Orange County
Laguna Hills, California, 92653, United States
San Diego Managed Care Group
San Diego, California, 92128, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, 80120, United States
Southeast Clinical Research
Chiefland, Florida, 32626, United States
Osler Medical, Inc. / Osler Clinical Research
Melbourne, Florida, 32901, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Gold Coast Research LLC
Weston, Florida, 33324, United States
PMI Health Research Group
Atlanta, Georgia, 30312, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Millennium Pain Center
Bloomington, Illinois, 61701, United States
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254, United States
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Gulf Coast Reserach
Baton Rouge, Louisiana, 70808, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
MAPS Applied Research Center
Edina, Minnesota, 55435, United States
Midwest Pharmaceutical Research, Inc.
City of Saint Peters, Missouri, 63376, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Four Seasons Hospice and Palliative Care
Flat Rock, North Carolina, 28731, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Riverhills Healthcare Research Division
Cincinnati, Ohio, 45219, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Medford Medical Clinic
Medford, Oregon, 97504, United States
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, 29621, United States
Singleton Health Center
Orangeburg, South Carolina, 29118, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Spokane Internal Medicine
Spokane, Washington, 99216, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Sostek
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Mark Sostek
AstraZeneca Pharmaceuticals, Wilm DE
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 24, 2008
Study Start
December 1, 2007
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
June 12, 2015
Results First Posted
June 12, 2015
Record last verified: 2015-05