A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
Public ClinicalTrials.gov record NCT01571362. 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 Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Study identification
- NCT ID
- NCT01571362
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 410 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
- Jun 2012 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Jun 2013 (Actual)
- Last update posted
- Apr 4, 2017
2012 – 2013
United States locations
- U.S. sites
- 52
- U.S. states
- 21
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Dedicated Clinical Research | Goodyear | Arizona | 85395 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Premier Research Group Limited | Phoenix | Arizona | 85027 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Med Center | Carmichael | California | 95608 | — |
| Med Investigations, Inc. | Fair Oaks | California | 95628 | — |
| Neuro-Pain Medical Center | Fresno | California | 93710 | — |
| Pacific Coast Pain Management Center | Laguna Hills | California | 92637 | — |
| Long Beach Center for Clinical Research - previous addresse | Long Beach | California | 90806 | — |
| Long Beach Center for Clinical Research | Long Beach | California | 90807 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | — |
| Lynn Institute of the Rockies Medical Centre | Colorado Springs | Colorado | 80907 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Ormond Medical Arts pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| The Office of Martin E. Hale, MD, PA | Plantation | Florida | 33317 | — |
| Accord Clinical Research, LLC- Duplicate 2 | Port Orange | Florida | 32129 | — |
| Accord Clinical Research, LLC- Duplicate | Port Orange | Florida | 32129 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| Mid-Atlantic Medical Research - Research Department | Hollywood | Maryland | 20636 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | 68134 | — |
| Office of Stephen H. Miller, M.D. | Las Vegas | Nevada | 89144 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | — |
| Research Across America | New York | New York | 10022 | — |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| Columbus Clinical Research | Columbus | Ohio | 43213 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Associated Orthopedics | Oklahoma City | Oklahoma | 73119 | — |
| Hillcrest Clinical Research | Oklahoma City | Oklahoma | 73119 | — |
| Allegheny Pain Management, PC | Altoona | Pennsylvania | 16602 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Pain Research of Charleston | Charleston | South Carolina | 29406 | — |
| TLM Medical Services | Columbia | South Carolina | 29204 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Quality Research Inc. | San Antonio | Texas | 78209 | — |
| Lee Medical Associates | San Antonio | Texas | 78229 | — |
| Progressive Clinical Research, P.A. | San Antonio | Texas | 78229 | — |
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 NCT01571362, 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 Apr 4, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01571362 live on ClinicalTrials.gov.