Opioid Induced Constipation (OIC) Clinical Trial
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 (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.
| Status | Completed |
| Enrollment | 207 |
| Est. completion date | April 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico |
| United States | Anderson Gastroenterology Associates, LLC | Anderson | South Carolina |
| United States | PMI Health Research Group | Atlanta | Georgia |
| United States | Gulf Coast Reserach | Baton Rouge | Louisiana |
| United States | Millennium Pain Center | Bloomington | Illinois |
| United States | Northwest Clinical Trials | Boise | Idaho |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | ClinSearch, LLC | Chattanooga | Tennessee |
| United States | Pain & Rehabilitation Clinic of Chicago | Chicago | Illinois |
| United States | Southeast Clinical Research | Chiefland | Florida |
| United States | Riverhills Healthcare Research Division | Cincinnati | Ohio |
| United States | MAPS Applied Research Center | Edina | Minnesota |
| United States | Centennial Medical Group | Elkridge | Maryland |
| United States | Four Seasons Hospice and Palliative Care | Flat Rock | North Carolina |
| United States | Long Island Gastrointestinal Research Group | Great Neck | New York |
| United States | Tennessee Valley Pain Consultants / Center for Pain Management | Huntsville | Alabama |
| United States | Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana |
| United States | Therapeutic Research Institute of Orange County | Laguna Hills | California |
| United States | Pain Treatment Center of the Bluegrass | Lexington | Kentucky |
| United States | Arapahoe Gastroenterology, PC | Littleton | Colorado |
| United States | Medford Medical Clinic | Medford | Oregon |
| United States | Osler Medical, Inc. / Osler Clinical Research | Melbourne | Florida |
| United States | Singleton Health Center | Orangeburg | South Carolina |
| United States | Deerfoot Internal Medicine | Pinson | Alabama |
| United States | Lifetree Clinical Research | Salt Lake City | Utah |
| United States | San Diego Managed Care Group | San Diego | California |
| United States | Spokane Internal Medicine | Spokane | Washington |
| United States | Midwest Pharmaceutical Research, Inc. | St. Peters | Missouri |
| United States | Genova Clinical Research, Inc. | Tucson | Arizona |
| United States | Options Health Research | Tulsa | Oklahoma |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| United States | Gold Coast Research LLC | Weston | Florida |
| United States | The Center for Clinical Research, LLC | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Nektar Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | Days 1 through 28 | No |
| Secondary | 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. | Days 1 through 28 | No |
| Secondary | 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. | Days 1 through 28 | No |