Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

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

Key facts

Study ID

NCT01043263

Run by

Grünenthal GmbH

People needed

236

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2015-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Paradigm Clinical — Tucson, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Quality of Life Medical & Research Center — Tuscon, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials, Inc. — Anaheim, California, United States
• Associated Pharmaceutical Research Center, Inc. — Buena Park, California, United States
• Catalina Research Institute, LLC — Chino, California, United States
• Paradigm Clinical Research — Garden Grove, California, United States
• Synergy Escondido — La Mesa, California, United States
• Triwest Research Associates — La Mesa, California, 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
• Synergy Research Center — National City, California, United States
• Northern California Research — Sacramento, California, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Avail Clinical Research — DeLand, Florida, United States
• Neuropsychiatric Research Center of SW Florida — Fort Myers, Florida, United States
• CNS Healthcare — Jacksonville, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Behavioral Clinical Research, Inc. — Lauderhill, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• CNS Health — Orlando, Florida, United States
• Matthew Doust, MD — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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