Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
Public ClinicalTrials.gov record NCT01043263. 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 IIB, Randomized, Double-blind, Two-arm, Multi-center, Placebo-controlled, Study to Assess the Efficacy and Safety of EN3324 (Axomadol) in Subjects With Moderate to Severe Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain
Study identification
- NCT ID
- NCT01043263
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 236 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
- Nov 30, 2009
- Primary completion
- May 31, 2011
- Completion
- May 31, 2011
- Last update posted
- Apr 1, 2015
2009 – 2011
United States locations
- U.S. sites
- 59
- U.S. states
- 19
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Matthew Doust, MD | Phoenix | Arizona | 85050 | — |
| Paradigm Clinical | Tucson | Arizona | 85705 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| Genova Clinical Research, Inc. | Tucson | Arizona | 85741 | — |
| Quality of Life Medical & Research Center | Tuscon | Arizona | 85715 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Orange County Clinical Trials, Inc. | Anaheim | California | 92801 | — |
| Associated Pharmaceutical Research Center, Inc. | Buena Park | California | 90620 | — |
| Catalina Research Institute, LLC | Chino | California | 91710 | — |
| Paradigm Clinical Research | Garden Grove | California | 92844 | — |
| Synergy Escondido | La Mesa | California | 91942 | — |
| Triwest Research Associates | La Mesa | California | 91942 | — |
| LBCCR | Long Beach | California | 90806 | — |
| Pacific Institute for Med Research | Los Angeles | California | 90024 | — |
| Samaritan Center for Medical Research | Los Gatos | California | 95032 | — |
| Synergy Research Center | National City | California | 91950 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Mountain View Clinical Research | Denver | Colorado | 80209 | — |
| Avail Clinical Research | DeLand | Florida | 32720 | — |
| Neuropsychiatric Research Center of SW Florida | Fort Myers | Florida | 33912 | — |
| CNS Healthcare | Jacksonville | Florida | 32216 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Behavioral Clinical Research, Inc. | Lauderhill | Florida | 33319 | — |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | — |
| CNS Health | Orlando | Florida | 32806 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Altas Orthopedics & Sports Medicine | Orlando | Florida | 32822 | — |
| Gold Coast Research LLC. | Plantation | Florida | 33324 | — |
| Medex Healthcare Research, Inc. | Chicago | Illinois | 60603 | — |
| Center for Pain Management Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | — |
| Integrated Clinical Trial Services Inc. | West Des Moines | Iowa | 50265 | — |
| International Clinical Research Institute Inc. | Overland Park | Kansas | 66211 | — |
| Robert Wagner, MD | Crestview Hills | Kentucky | 41017 | — |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | — |
| Beacon Clinical Research LLC | Brockton | Massachusetts | 02301 | — |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | — |
| Prime Care Research Associates | Florissant | Missouri | 63031 | — |
| Medex Health Research, Inc. | St Louis | Missouri | 63117 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Office of Danka Micheals, MD | Las Vegas | Nevada | 89128 | — |
| Stephen Miller, MD | Las Vegas | Nevada | 89144 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| New Hanover Medical Research | Wilmington | North Carolina | 28401 | — |
| The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A. | Winstom-Salem | North Carolina | 27103 | — |
| David Schneider, MD | Cincinnari | Ohio | 45245 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Bone, Joint & Spine Surgeons, Inc. | Toledo | Ohio | 43623 | — |
| Neurology & Neruoscience Center of Ohio | Toledo | Ohio | 43623 | — |
| Alleghany Pain Management, PC | Altoona | Pennsylvania | 16602 | — |
| Paragon Clinical Research Inc. | Cranston | Rhode Island | 02920 | — |
| Omega Clinical Research | Warwick | Rhode Island | 02818 | — |
| Future Search Trials | Ausitn | Texas | 78756 | — |
| Austin Diagnostic Clinic | Ausitn | Texas | 78758 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Medex Healthcare Research | Houston | Texas | 77074 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
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 NCT01043263, 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 1, 2015 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01043263 live on ClinicalTrials.gov.