ClinicalTrials.gov record
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
ClinicalTrials.gov ID: NCT01427270
Public ClinicalTrials.gov record NCT01427270. 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 Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
Study identification
- NCT ID
- NCT01427270
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 455 participants
Conditions and interventions
Conditions
Interventions
Drug
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
- Aug 2011 (Type not available)
- Primary completion
- Oct 2014 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Nov 7, 2014
2011 – 2014
United States locations
- U.S. sites
- 170
- U.S. states
- 32
- U.S. cities
- 140
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site | Alabaster | Alabama | 35007 | — |
| Investigational Site | Birmingham | Alabama | 35242 | — |
| Investigational Site | Gulf Shores | Alabama | 36542 | — |
| Investigational Site | Homewood | Alabama | 35209 | — |
| Investigational Site | Huntsville | Alabama | 35801 | — |
| Investigational Site | Mobile | Alabama | 36608 | — |
| Investigational Site | Goodyear | Arizona | 85395-2511 | — |
| Investigational Site | Goodyear | Arizona | 85395 | — |
| Investigational Site | Phoenix | Arizona | 85018 | — |
| Investigational Site | Phoenix | Arizona | 85027 | — |
| Investigational Site | Tempe | Arizona | 85282 | — |
| Investigational Site | Tucson | Arizona | 85704 | — |
| Investigational Site | Hot Springs | Arkansas | 71901 | — |
| Investigational Site | Little Rock | Arkansas | 72211 | — |
| Investigational Site | Anaheim | California | 92801 | — |
| Investigational Site | Anaheim | California | 92804 | — |
| Investigational Site | Anaheim | California | 92805 | — |
| Investigational Site | Chino | California | 91710 | — |
| Investigational Site | Fresno | California | 93720 | — |
| Investigational Site | Fresno | California | 93726 | — |
| Investigational Site | Glendale | California | 91206 | — |
| Investigational Site | La Mesa | California | 91942 | — |
| Investigational Site | Laguna Hills | California | 92637 | — |
| Investigational Site | Long Beach | California | 90806 | — |
| Investigational Site | Los Angeles | California | 90017 | — |
| Investigational Site | Los Angeles | California | 90025 | — |
| Investigational Site | Los Angeles | California | 90036 | — |
| Investigational Site | Los Gatos | California | 95032 | — |
| Investigational Site | National City | California | 91950 | — |
| Investigational Site | North Hollywood | California | 91606 | — |
| Investigational Site | Oceanside | California | 92056 | — |
| Investigational Site | Paramount | California | 90723 | — |
| Investigational Site | Richmond | California | 94806 | — |
| Investigational Site | Roseville | California | 95661 | — |
| Investigational Site | Sacramento | California | 95823 | — |
| Investigational Site | Sacramento | California | 95842 | — |
| Investigational Site | San Diego | California | 92114 | — |
| Investigational Site | Santa Ana | California | 92701 | — |
| Investigational Site | Santa Clarita | California | 91350 | — |
| Investigational Site | Valley Village | California | 91607 | — |
| Investigational Site | Golden | Colorado | 80401 | — |
| Investigational Site | New Haven | Connecticut | 06511 | — |
| Investigational Site | Waterbury | Connecticut | 06708 | — |
| Investigational Site | Aventura | Florida | 33180 | — |
| Investigational Site | Boynton Beach | Florida | 33472 | — |
| Investigational Site | Bradenton | Florida | 34209 | — |
| Investigational Site | Clearwater | Florida | 33765 | — |
| Investigational Site | Clermont | Florida | 34711 | — |
| Investigational Site | Coral Gables | Florida | 33134 | — |
| Investigational Site | Daytona Beach | Florida | 32117 | — |
| Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| Investigational Site | Hialeah | Florida | 33012 | — |
| Investigational Site | Hialeah | Florida | 33013 | — |
| Investigational Site | Inverness | Florida | 34452 | — |
| Investigational Site | Jacksonville | Florida | 32216 | — |
| Investigational Site | Jacksonville | Florida | 32257 | — |
| Investigational Site | Jupiter | Florida | 33458 | — |
| Investigational Site | Miami | Florida | 33125 | — |
| Investigational Site | Miami | Florida | 33126 | — |
| Investigational Site | Miami | Florida | 33135 | — |
| Investigational Site | Miami | Florida | 33143 | — |
| Investigational Site | Miami | Florida | 33185 | — |
| Investigational Site | Miami Lakes | Florida | 33014 | — |
| Investigational Site | Naples | Florida | 34110 | — |
| Investigational Site | Naples | Florida | 34113 | — |
| Investigational Site | New Port Richey | Florida | 34652 | — |
| Investigational Site | North Miami Beach | Florida | 33162 | — |
| Investigational Site | Orlando | Florida | 32806 | — |
| Investigational Site | Oviedo | Florida | 32765 | — |
| Investigational Site | Pinellas Park | Florida | 33781 | — |
| Investigational Site | Pinellas Park | Florida | 33782 | — |
| Investigational Site | Plantation | Florida | 33317 | — |
| Investigational Site | Port Orange | Florida | 32129 | — |
| Investigational Site | Sanford | Florida | 32771 | — |
| Investigational Site | South Miami | Florida | 33143 | — |
| Investigational Site | Tamarac | Florida | 33321 | — |
| Investigational Site | Tampa | Florida | 33607 | — |
| Investigational Site | Tampa | Florida | 33613 | — |
| Investigational Site | Wellington | Florida | 33414 | — |
| Investigational Site | Austell | Georgia | 30106 | — |
| Investigational Site | Blue Ridge | Georgia | 30513 | — |
| Investigational Site | Canton | Georgia | 30114 | — |
| Investigational Site | Columbus | Georgia | 31904 | — |
| Investigational Site | Johns Creek | Georgia | 30097 | — |
| Investigational Site | Marietta | Georgia | 30060 | — |
| Investigational Site | Perry | Georgia | 31069 | — |
| Investigational Site | Savannah | Georgia | 31405 | — |
| Investigational Site | Boise | Idaho | 83702 | — |
| Investigational Site | Meridian | Idaho | 83642 | — |
| Investigational Site | Bloomington | Illinois | 61701 | — |
| Investigational Site | Chicago | Illinois | 60657 | — |
| Investigational Site | Evansville | Indiana | 47714 | — |
| Investigational Site | Kansas City | Kansas | 66160 | — |
| Investigational Site | Wichita | Kansas | 67203 | — |
| Investigational Site | Lexington | Kentucky | 40504 | — |
| Investigational Site | Madisonville | Kentucky | 42431 | — |
| Investigational Site | Baton Rouge | Louisiana | 70809 | — |
| Investigational Site | Covington | Louisiana | 70435 | — |
| Investigational Site | Marrero | Louisiana | 70072 | — |
| Investigational Site | Metairie | Louisiana | 70006 | — |
| Investigational Site | Hollywood | Maryland | 20636 | — |
| Investigational Site | Fall River | Massachusetts | 02720 | — |
| Investigational Site | North Attleboro | Massachusetts | 02760 | — |
| Investigational Site | Bay City | Michigan | 48706 | — |
| Investigational Site | Pinconning | Michigan | 48650 | — |
| Investigational Site | Rochester | Michigan | 48307 | — |
| Investigational Site | Troy | Michigan | 48085 | — |
| Investigational Site | Hazelwood | Missouri | 63042 | — |
| Investigational Site | St Louis | Missouri | 63128 | — |
| Investigational Site | St Louis | Missouri | 63141 | — |
| Investigational Site | Las Vegas | Nevada | 89119 | — |
| Investigational Site | Stratford | New Jersey | 08084 | — |
| Investigational Site | Toms River | New Jersey | 08755 | — |
| Investigational Site | Voorhees Township | New Jersey | 08034 | — |
| Investigational Site | Albuquerque | New Mexico | 87106 | — |
| Investigational Site | Cedarhurst | New York | 11516 | — |
| Investigational Site | Great Neck | New York | 11023 | — |
| Investigational Site | New Windsor | New York | 12553 | — |
| Investigational Site | New York | New York | 10022 | — |
| Investigational Site | North Massapequa | New York | 11758 | — |
| Investigational Site | Williamsville | New York | 14221 | — |
| Investigational Site | Elkin | North Carolina | 28621 | — |
| Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site | Beavercreek | Ohio | 45432 | — |
| Investigational Site | Cincinnati | Ohio | 45242 | — |
| Investigational Site | Cleveland | Ohio | 44122 | — |
| Investigational Site | Columbus | Ohio | 43210 | — |
| Investigational Site | Columbus | Ohio | 43214 | — |
| Investigational Site | Franklin | Ohio | 45005 | — |
| Investigational Site | Groveport | Ohio | 43125 | — |
| Investigational Site | Toledo | Ohio | 43623 | — |
| Investigational Site | Oklahoma City | Oklahoma | 73119 | — |
| Investigational Site | Altoona | Pennsylvania | 16602 | — |
| Investigational Site | Jenkintown | Pennsylvania | 19046 | — |
| Investigational Site | Johnstown | Pennsylvania | 15904 | — |
| Investigational Site | Philadelphia | Pennsylvania | 19152 | — |
| Investigational Site | Phoenixville | Pennsylvania | 19460 | — |
| Investigational Site | Tipton | Pennsylvania | 16684 | — |
| Investigational Site | Warwick | Rhode Island | 02886 | — |
| Investigational Site | Myrtle Beach | South Carolina | 29588 | — |
| Investigational Site | Spartanburg | South Carolina | 29303 | — |
| Investigational Site | Franklin | Tennessee | 37067 | — |
| Investigational Site | New Tazewell | Tennessee | 37825 | — |
| Investigational Site | Arlington | Texas | 76011 | — |
| Investigational Site | Athens | Texas | 75751 | — |
| Investigational Site | Austin | Texas | 78756 | — |
| Investigational Site | Dallas | Texas | 75231 | — |
| Investigational Site | Dallas | Texas | 75251 | — |
| Investigational Site | Houston | Texas | 77005 | — |
| Investigational Site | Houston | Texas | 77024 | — |
| Investigational Site | Houston | Texas | 77025 | — |
| Investigational Site | Houston | Texas | 77030 | — |
| Investigational Site | Houston | Texas | 77057 | — |
| Investigational Site | Houston | Texas | 77065 | — |
| Investigational Site | Houston | Texas | 77074 | — |
| Investigational Site | Houston | Texas | 77098 | — |
| Investigational Site | Humble | Texas | 77338 | — |
| Investigational Site | North Richland Hills | Texas | 76180 | — |
| Investigational Site | Plano | Texas | 75075 | — |
| Investigational Site | San Antonio | Texas | 78229 | — |
| Investigational Site | San Antonio | Texas | 78238 | — |
| Investigational Site | Sugar Land | Texas | 77478 | — |
| Investigational Site | Tomball | Texas | 77375 | — |
| Investigational Site | Clinton | Utah | 84015 | — |
| Investigational Site | Salt Lake City | Utah | 84102 | — |
| Investigational Site | Salt Lake City | Utah | 84107 | — |
| Investigational Site | West Jordan | Utah | 84088 | — |
| Investigational Site | Richmond | Virginia | 23220 | — |
| Investigational Site | Richmond | Virginia | 23235 | — |
| Investigational Site | Virginia Beach | Virginia | 23454 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01427270, 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 Nov 7, 2014 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01427270 live on ClinicalTrials.gov.