Clinical trial NCT00600119: A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Induced Constipation (OIC)
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
First posted: 2008-01-24
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
timeFrame: Days 1 through 7
Secondary outcomes:
measure: Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
timeFrame: Days 1 through 28
measure: Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
timeFrame: Days 1 through 28
measure: Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
timeFrame: Days 1 through 28
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Tennessee Valley Pain Consultants / Center for Pain Management
state: Alabama
city: Pinson
country: United States
facility: Deerfoot Internal Medicine
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Laguna Hills
country: United States
facility: Therapeutic Research Institute of Orange County
state: California
city: San Diego
country: United States
facility: San Diego Managed Care Group
state: California
city: Littleton
country: United States
facility: Arapahoe Gastroenterology, PC
state: Colorado
city: Chiefland
country: United States
facility: Southeast Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Osler Medical, Inc. / Osler Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Atlanta
country: United States
facility: PMI Health Research Group
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Pain & Rehabilitation Clinic of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Lexington
country: United States
facility: Pain Treatment Center of the Bluegrass
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Reserach
state: Louisiana
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Edina
country: United States
facility: MAPS Applied Research Center
state: Minnesota
city: St. Peters
country: United States
facility: Midwest Pharmaceutical Research, Inc.
state: Missouri
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Flat Rock
country: United States
facility: Four Seasons Hospice and Palliative Care
state: North Carolina
city: Winston Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Riverhills Healthcare Research Division
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic
state: Oregon
city: Anderson
country: United States
facility: Anderson Gastroenterology Associates, LLC
state: South Carolina
city: Orangeburg
country: United States
facility: Singleton Health Center
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Spokane
country: United States
facility: Spokane Internal Medicine
state: Washington
Study officials:
affiliation: AstraZeneca Pharmaceuticals, Wilm DE
name: Mark Sostek
role: STUDY_DIRECTOR
References: