Back to resultsA Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Primary Purpose
Opioid Induced Constipation (OIC)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo
NKTR-118
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Induced Constipation (OIC) focused on measuring NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
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
Sites / Locations
- Tennessee Valley Pain Consultants / Center for Pain Management
- Deerfoot Internal Medicine
- Genova Clinical Research, Inc.
- Therapeutic Research Institute of Orange County
- San Diego Managed Care Group
- Arapahoe Gastroenterology, PC
- Southeast Clinical Research
- Osler Medical, Inc. / Osler Clinical Research
- Palm Beach Research Center
- Gold Coast Research LLC
- PMI Health Research Group
- Northwest Clinical Trials
- Millennium Pain Center
- Pain & Rehabilitation Clinic of Chicago
- Investigative Clinical Research of Indiana, LLC
- Pain Treatment Center of the Bluegrass
- Gulf Coast Reserach
- Centennial Medical Group
- MAPS Applied Research Center
- Midwest Pharmaceutical Research, Inc.
- Lovelace Scientific Resources, Inc.
- Long Island Gastrointestinal Research Group
- Four Seasons Hospice and Palliative Care
- The Center for Clinical Research, LLC
- Gabrail Cancer Center
- Riverhills Healthcare Research Division
- Options Health Research
- Medford Medical Clinic
- Anderson Gastroenterology Associates, LLC
- Singleton Health Center
- ClinSearch, LLC
- Lifetree Clinical Research
- Spokane Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
A
B
Arm Description
Placebo
NKTR-118
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Full Information
NCT ID
NCT00600119
First Posted
January 11, 2008
Last Updated
May 28, 2015
Sponsor
AstraZeneca
Collaborators
Nektar Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00600119
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Nektar Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Induced Constipation (OIC)
Keywords
NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
B
Arm Type
Experimental
Arm Description
NKTR-118
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, oral, once daily (QD)
Intervention Type
Drug
Intervention Name(s)
NKTR-118
Intervention Description
5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Primary Outcome Measure Information:
Title
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Description
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.
Time Frame
Days 1 through 7
Secondary Outcome Measure Information:
Title
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Description
Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
Time Frame
Days 1 through 28
Title
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Description
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Time Frame
Days 1 through 28
Title
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Description
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Time Frame
Days 1 through 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sostek
Organizational Affiliation
AstraZeneca Pharmaceuticals, Wilm DE
Official's Role
Study Director
Facility Information:
Facility Name
Tennessee Valley Pain Consultants / Center for Pain Management
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Deerfoot Internal Medicine
City
Pinson
State/Province
Alabama
ZIP/Postal Code
35126
Country
United States
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Therapeutic Research Institute of Orange County
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
San Diego Managed Care Group
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Arapahoe Gastroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Southeast Clinical Research
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Osler Medical, Inc. / Osler Clinical Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Gold Coast Research LLC
City
Weston
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
PMI Health Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Pain & Rehabilitation Clinic of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Pain Treatment Center of the Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Gulf Coast Reserach
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
MAPS Applied Research Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Midwest Pharmaceutical Research, Inc.
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Four Seasons Hospice and Palliative Care
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Riverhills Healthcare Research Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Medford Medical Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Anderson Gastroenterology Associates, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Singleton Health Center
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Spokane Internal Medicine
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1143&filename=07-IN-NX003_CSR_Synopsis.pdf
Description
07-IN-NX003 CSR Synopsis.pdf
Learn more about this trial
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
We'll reach out to this number within 24 hrs