A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Public ClinicalTrials.gov record NCT00600119. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00600119
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 207 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2007 (Type not available)
- Primary completion
- Mar 2009 (Actual)
- Completion
- Apr 2009 (Actual)
- Last update posted
- Jun 12, 2015
2007 – 2009
United States locations
- U.S. sites
- 33
- U.S. states
- 24
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tennessee Valley Pain Consultants / Center for Pain Management | Huntsville | Alabama | 35801 | — |
| Deerfoot Internal Medicine | Pinson | Alabama | 35126 | — |
| Genova Clinical Research, Inc. | Tucson | Arizona | 85741 | — |
| Therapeutic Research Institute of Orange County | Laguna Hills | California | 92653 | — |
| San Diego Managed Care Group | San Diego | California | 92128 | — |
| Arapahoe Gastroenterology, PC | Littleton | Colorado | 80120 | — |
| Southeast Clinical Research | Chiefland | Florida | 32626 | — |
| Osler Medical, Inc. / Osler Clinical Research | Melbourne | Florida | 32901 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Gold Coast Research LLC | Weston | Florida | 33324 | — |
| PMI Health Research Group | Atlanta | Georgia | 30312 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Millennium Pain Center | Bloomington | Illinois | 61701 | — |
| Pain & Rehabilitation Clinic of Chicago | Chicago | Illinois | 60610 | — |
| Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana | 46254 | — |
| Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | — |
| Gulf Coast Reserach | Baton Rouge | Louisiana | 70808 | — |
| Centennial Medical Group | Elkridge | Maryland | 21075 | — |
| MAPS Applied Research Center | Edina | Minnesota | 55435 | — |
| Midwest Pharmaceutical Research, Inc. | City of Saint Peters | Missouri | 63376 | — |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87108 | — |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | — |
| Four Seasons Hospice and Palliative Care | Flat Rock | North Carolina | 28731 | — |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Riverhills Healthcare Research Division | Cincinnati | Ohio | 45219 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| Medford Medical Clinic | Medford | Oregon | 97504 | — |
| Anderson Gastroenterology Associates, LLC | Anderson | South Carolina | 29621 | — |
| Singleton Health Center | Orangeburg | South Carolina | 29118 | — |
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
| Spokane Internal Medicine | Spokane | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00600119, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2015 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00600119 live on ClinicalTrials.gov.