Clinical trial NCT01043263: Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low Back Pain
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
timeFrame: Change from baseline [Day 0] to final visit [Day 112]
Secondary outcomes:
measure: To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
timeFrame: Change from baseline [Day 0] to final visit [Day 112]
measure: To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.
timeFrame: Change from baseline [Day 0] to final visit [Day 112]
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Matthew Doust, MD
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Tuscon
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials, Inc.
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Garden Grove
country: United States
facility: Paradigm Clinical Research
state: California
city: La Mesa
country: United States
facility: Synergy Escondido
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates
state: California
city: Long Beach
country: United States
facility: LBCCR
state: California
city: Los Angeles
country: United States
facility: Pacific Institute for Med Research
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: National City
country: United States
facility: Synergy Research Center
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of SW Florida
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Lauderhill
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Orlando
country: United States
facility: CNS Health
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Orlando
country: United States
facility: Altas Orthopedics & Sports Medicine
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research LLC.
state: Florida
city: Chicago
country: United States
facility: Medex Healthcare Research, Inc.
state: Illinois
city: Chicago
country: United States
facility: Center for Pain Management Rehabilitation Institute of Chicago
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services Inc.
state: Iowa
city: Overland Park
country: United States
facility: International Clinical Research Institute Inc.
state: Kansas
city: Crestview Hills
country: United States
facility: Robert Wagner, MD
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Brockton
country: United States
facility: Beacon Clinical Research LLC
state: Massachusetts
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Florissant
country: United States
facility: Prime Care Research Associates
state: Missouri
city: St. Louis
country: United States
facility: Medex Health Research, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Office of Danka Micheals, MD
state: Nevada
city: Las Vegas
country: United States
facility: Stephen Miller, MD
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Winstom-Salem
country: United States
facility: The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
state: North Carolina
city: Cincinnari
country: United States
facility: David Schneider, MD
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Toledo
country: United States
facility: Bone, Joint & Spine Surgeons, Inc.
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neruoscience Center of Ohio
state: Ohio
city: Altoona
country: United States
facility: Alleghany Pain Management, PC
state: Pennsylvania
city: Cranston
country: United States
facility: Paragon Clinical Research Inc.
state: Rhode Island
city: Warwick
country: United States
facility: Omega Clinical Research
state: Rhode Island
city: Ausitn
country: United States
facility: Future Search Trials
state: Texas
city: Ausitn
country: United States
facility: Austin Diagnostic Clinic
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Medex Healthcare Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
Study officials:
References: