ClinicalTrials.gov record
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01427283
Public ClinicalTrials.gov record NCT01427283. 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 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 controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
Study identification
- NCT ID
- NCT01427283
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 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
- Feb 12, 2015
2011 – 2014
United States locations
- U.S. sites
- 149
- U.S. states
- 32
- U.S. cities
- 117
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site | Alabaster | Alabama | 35007 | — |
| Investigational Site | Birmingham | Alabama | 35213 | — |
| Investigational Site | Birmingham | Alabama | 35216 | — |
| Investigational Site | Foley | Alabama | 36535 | — |
| Investigational Site | Mobile | Alabama | 36608 | — |
| Investigational Site | Mesa | Arizona | 85202 | — |
| Investigational Site | Phoenix | Arizona | 85020 | — |
| Investigational Site | Phoenix | Arizona | 85021 | — |
| Investigational Site | Sun Lakes | Arizona | 85248 | — |
| Investigational Site | Tucson | Arizona | 85704 | — |
| Investigational Site | Tucson | Arizona | 85712 | — |
| Investigational Site | Little Rock | Arkansas | 72211 | — |
| Investigational Site | Sherwood | Arkansas | 72120 | — |
| Investigational Site | Anaheim | California | 92801 | — |
| Investigational Site | Anaheim | California | 92804 | — |
| Investigational Site | Artesia | California | 90701 | — |
| Investigational Site | Cerritos | California | 90703 | — |
| Investigational Site | Chino | California | 91710 | — |
| Investigational Site | El Cajon | California | 92020 | — |
| Investigational Site | Encino | California | 91436 | — |
| Investigational Site | Fountain Valley | California | 92708 | — |
| Investigational Site | Fresno | California | 93720 | — |
| Investigational Site | Garden Grove | California | 92843 | — |
| Investigational Site | Garden Grove | California | 92844 | — |
| Investigational Site | Laguna Hills | California | 92653 | — |
| Investigational Site | Lakewood | California | 90712 | — |
| Investigational Site | Lincoln | California | 95648 | — |
| Investigational Site | Lomita | California | 90717 | — |
| Investigational Site | Long Beach | California | 90806 | — |
| Investigational Site | Oceanside | California | 92054 | — |
| Investigational Site | Orange | California | 92868 | — |
| Investigational Site | Paramount | California | 90723 | — |
| Investigational Site | Sacramento | California | 95823 | — |
| Investigational Site | San Bernardino | California | 92408 | — |
| Investigational Site | San Diego | California | 92103 | — |
| Investigational Site | San Diego | California | 92114 | — |
| Investigational Site | Thousand Oaks | California | 91360 | — |
| Investigational Site | Torrance | California | 90509 | — |
| Investigational Site | Colorado Springs | Colorado | 80907 | — |
| Investigational Site | Colorado Springs | Colorado | 80909 | — |
| Investigational Site | Denver | Colorado | 80246 | — |
| Investigational Site | Golden | Colorado | 80401 | — |
| Investigational Site | Aventura | Florida | 33180 | — |
| Investigational Site | Bradenton | Florida | 34209 | — |
| Investigational Site | Chiefland | Florida | 32626 | — |
| Investigational Site | Clermont | Florida | 34711 | — |
| Investigational Site | Daytona Beach | Florida | 32117 | — |
| Investigational Site | DeLand | Florida | 32720 | — |
| Investigational Site | Edgewater | Florida | 32132 | — |
| Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| Investigational Site | Fort Myers | Florida | 33916 | — |
| Investigational Site | Hialeah | Florida | 33010 | — |
| Investigational Site | Hialeah | Florida | 33012 | — |
| Investigational Site | Inverness | Florida | 34452 | — |
| Investigational Site | Jacksonville | Florida | 32216 | — |
| Investigational Site | Jacksonville | Florida | 32256 | — |
| Investigational Site | Jacksonville | Florida | 32257 | — |
| Investigational Site | Miami | Florida | 33015 | — |
| Investigational Site | Miami | Florida | 33125 | — |
| Investigational Site | Miami | Florida | 33126 | — |
| Investigational Site | Miami | Florida | 33135 | — |
| Investigational Site | Miami | Florida | 33136 | — |
| Investigational Site | Miami | Florida | 33144 | — |
| Investigational Site | Miami | Florida | 33145 | — |
| Investigational Site | Miami | Florida | 33155 | — |
| Investigational Site | Miami | Florida | 33165 | — |
| Investigational Site | Miami | Florida | 33185 | — |
| Investigational Site | Miami Beach | Florida | 33140 | — |
| Investigational Site | Naples | Florida | 34110 | — |
| Investigational Site | Naples | Florida | 34113 | — |
| Investigational Site | New Smyrna Beach | Florida | 32168 | — |
| Investigational Site | North Miami | Florida | 33161 | — |
| Investigational Site | Oldsmar | Florida | 34677 | — |
| Investigational Site | Orlando | Florida | 32806 | — |
| Investigational Site | Oviedo | Florida | 32765 | — |
| Investigational Site | Plantation | Florida | 33317 | — |
| Investigational Site | Tamarac | Florida | 33321 | — |
| Investigational Site | Tampa | Florida | 33607 | — |
| Investigational Site | West Palm Beach | Florida | 33409 | — |
| Investigational Site | Atlanta | Georgia | 30308 | — |
| Investigational Site | Austell | Georgia | 30106 | — |
| Investigational Site | Snellville | Georgia | 30078 | — |
| Investigational Site | Boise | Idaho | 83704 | — |
| Investigational Site | Boise | Idaho | 83713 | — |
| Investigational Site | Chicago | Illinois | 60616 | — |
| Investigational Site | Chicago | Illinois | 60622 | — |
| Investigational Site | Chicago | Illinois | 60657 | — |
| Investigational Site | Evansville | Indiana | 47714 | — |
| Investigational Site | Indianapolis | Indiana | 46250 | — |
| Investigational Site | Michigan City | Indiana | 46360 | — |
| Investigational Site | Wichita | Kansas | 67203 | — |
| Investigational Site | Edgewood | Kentucky | 41017 | — |
| Investigational Site | Lake Charles | Louisiana | 70601 | — |
| Investigational Site | Monroe | Louisiana | 71201 | — |
| Investigational Site | New Orleans | Louisiana | 70119 | — |
| Investigational Site | Pikesville | Maryland | 21208 | — |
| Investigational Site | Brockton | Massachusetts | 02301 | — |
| Investigational Site | Worcester | Massachusetts | 01605 | — |
| Investigational Site | Florissant | Missouri | 63031 | — |
| Investigational Site | Las Vegas | Nevada | 89119 | — |
| Investigational Site | Atco | New Jersey | 08004 | — |
| Investigational Site | Great Neck | New York | 11023 | — |
| Investigational Site | Kew Gardens | New York | 11415 | — |
| Investigational Site | New York | New York | 10023 | — |
| Investigational Site | Rochester | New York | 14618 | — |
| Investigational Site | Williamsville | New York | 14221 | — |
| Investigational Site | Durham | North Carolina | 27710 | — |
| Investigational Site | Elkin | North Carolina | 28621 | — |
| Investigational Site | High Point | North Carolina | 27262 | — |
| Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site | Columbus | Ohio | 43213 | — |
| Investigational Site | Dayton | Ohio | 45406 | — |
| Investigational Site | Moraine | Ohio | 45439 | — |
| Investigational Site | Toledo | Ohio | 43614 | — |
| Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| Investigational Site | Oklahoma City | Oklahoma | 73109 | — |
| Investigational Site | Oklahoma City | Oklahoma | 73119 | — |
| Investigational Site | Eugene | Oregon | 97404 | — |
| Investigational Site | Jenkintown | Pennsylvania | 19046 | — |
| Investigational Site | Levittown | Pennsylvania | 19056 | — |
| Investigational Site | Mechanicsburg | Pennsylvania | 17055 | — |
| Investigational Site | Pittsburgh | Pennsylvania | 15215 | — |
| Investigational Site | Red Lion | Pennsylvania | 17356 | — |
| Investigational Site | State College | Pennsylvania | 16801 | — |
| Investigational Site | Warwick | Rhode Island | 02886 | — |
| Investigational Site | Charleston | South Carolina | 29406 | — |
| Investigational Site | Myrtle Beach | South Carolina | 29588 | — |
| Investigational Site | Rapid City | South Dakota | 57702 | — |
| Investigational Site | Jackson | Tennessee | 38305 | — |
| Investigational Site | Allen | Texas | 75013 | — |
| Investigational Site | Austin | Texas | 78731 | — |
| Investigational Site | Dallas | Texas | 75203 | — |
| Investigational Site | Dallas | Texas | 75218 | — |
| Investigational Site | Dallas | Texas | 75231 | — |
| Investigational Site | Dallas | Texas | 75251 | — |
| Investigational Site | Houston | Texas | 77062 | — |
| Investigational Site | Houston | Texas | 77065 | — |
| Investigational Site | Houston | Texas | 77074 | — |
| Investigational Site | Houston | Texas | 77098 | — |
| Investigational Site | McKinney | Texas | 75070 | — |
| Investigational Site | North Richland Hills | Texas | 76180 | — |
| Investigational Site | Tomball | Texas | 77375 | — |
| Investigational Site | Orem | Utah | 84058 | — |
| Investigational Site | Salt Lake City | Utah | 84102 | — |
| Investigational Site | Salt Lake City | Utah | 84124 | — |
| Investigational Site | Danville | Virginia | 24541 | — |
| Investigational Site | Midlothian | Virginia | 23114 | — |
| Investigational Site | Richmond | Virginia | 23220 | — |
| Investigational Site | Bothell | Washington | 98011 | — |
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 NCT01427283, 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 Feb 12, 2015 · Synced Oct 24, 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 NCT01427283 live on ClinicalTrials.gov.