Chronic Low Back Pain Clinical Trial
— CLBPOfficial 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
| Verified date | March 2015 |
| Source | Grünenthal GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 236 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years of age or older - Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year. - Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent - Have a history of moderate to severe CLBP Exclusion Criteria: - Have evidence of or a history of alcohol and/or drug abuse - Have pain secondary to a confirmed or suspected neoplasm - Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study - Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Alleghany Pain Management, PC | Altoona | Pennsylvania |
| United States | Advanced Clinical Research Institute | Anaheim | California |
| United States | Orange County Clinical Trials, Inc. | Anaheim | California |
| United States | Austin Diagnostic Clinic | Ausitn | Texas |
| United States | Future Search Trials | Ausitn | Texas |
| United States | Comprehensive Clinical Research | Berlin | New Jersey |
| United States | Quest Research Institute | Bingham Farms | Michigan |
| United States | Beacon Clinical Research LLC | Brockton | Massachusetts |
| United States | Associated Pharmaceutical Research Center, Inc. | Buena Park | California |
| United States | Center for Pain Management Rehabilitation Institute of Chicago | Chicago | Illinois |
| United States | Medex Healthcare Research, Inc. | Chicago | Illinois |
| United States | Catalina Research Institute, LLC | Chino | California |
| United States | David Schneider, MD | Cincinnari | Ohio |
| United States | Community Research | Cincinnati | Ohio |
| United States | Paragon Clinical Research Inc. | Cranston | Rhode Island |
| United States | Robert Wagner, MD | Crestview Hills | Kentucky |
| United States | KRK Medical Research | Dallas | Texas |
| United States | Avail Clinical Research | DeLand | Florida |
| United States | Mountain View Clinical Research | Denver | Colorado |
| United States | Prime Care Research Associates | Florissant | Missouri |
| United States | Neuropsychiatric Research Center of SW Florida | Fort Myers | Florida |
| United States | Paradigm Clinical Research | Garden Grove | California |
| United States | Clinical Trial Network | Houston | Texas |
| United States | Medex Healthcare Research | Houston | Texas |
| United States | CNS Healthcare | Jacksonville | Florida |
| United States | Florida Institute of Medical Research | Jacksonville | Florida |
| United States | Synergy Escondido | La Mesa | California |
| United States | Triwest Research Associates | La Mesa | California |
| United States | Office of Danka Micheals, MD | Las Vegas | Nevada |
| United States | Stephen Miller, MD | Las Vegas | Nevada |
| United States | Behavioral Clinical Research, Inc. | Lauderhill | Florida |
| United States | LBCCR | Long Beach | California |
| United States | Pacific Institute for Med Research | Los Angeles | California |
| United States | Samaritan Center for Medical Research | Los Gatos | California |
| United States | North Star Medical Research, LLC | Middleburg Heights | Ohio |
| United States | Synergy Research Center | National City | California |
| United States | Segal Institute for Clinical Research | North Miami | Florida |
| United States | Altas Orthopedics & Sports Medicine | Orlando | Florida |
| United States | CNS Health | Orlando | Florida |
| United States | Compass Research | Orlando | Florida |
| United States | International Clinical Research Institute Inc. | Overland Park | Kansas |
| United States | Four Rivers Clinical Research | Paducah | Kentucky |
| United States | Matthew Doust, MD | Phoenix | Arizona |
| United States | Gold Coast Research LLC. | Plantation | Florida |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | Northern California Research | Sacramento | California |
| United States | Sun Research Institute | San Antonio | Texas |
| United States | Medex Health Research, Inc. | St. Louis | Missouri |
| United States | Sundance Clinical Research | St. Louis | Missouri |
| United States | Bone, Joint & Spine Surgeons, Inc. | Toledo | Ohio |
| United States | Neurology & Neruoscience Center of Ohio | Toledo | Ohio |
| United States | Genova Clinical Research, Inc. | Tucson | Arizona |
| United States | Paradigm Clinical | Tucson | Arizona |
| United States | Visions Clinical Research | Tucson | Arizona |
| United States | Quality of Life Medical & Research Center | Tuscon | Arizona |
| United States | Omega Clinical Research | Warwick | Rhode Island |
| United States | Integrated Clinical Trial Services Inc. | West Des Moines | Iowa |
| United States | New Hanover Medical Research | Wilmington | North Carolina |
| United States | The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A. | Winstom-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Grünenthal GmbH |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP. | Change from baseline [Day 0] to final visit [Day 112] | No | |
| Secondary | To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP. | Change from baseline [Day 0] to final visit [Day 112] | Yes | |
| Secondary | To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP. | Change from baseline [Day 0] to final visit [Day 112] | No |
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