Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
NCT ID: NCT01685684
Last Updated: 2020-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
740 participants
INTERVENTIONAL
2012-08-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oxycodone DETERx
Oxycodone DETERx
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
Placebo
Placebo
Placebo, divided into 2 doses, q12h
Interventions
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Oxycodone DETERx
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
Placebo
Placebo, divided into 2 doses, q12h
Eligibility Criteria
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Inclusion Criteria
* Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening.
* Must qualify for ATC opioid therapy for treatment of CLBP.
* Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score.
* Female subjects of childbearing potential will use an acceptable method of birth control.
* Must be in general good health based on screening physical examination.
* Must be willing and able to comply with all study procedures and visit requirements.
Exclusion Criteria
* A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus.
* A surgical procedure for back pain within 6 months prior to the Screening Visit.
* Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy).
* Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability.
* Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems.
* Known history of alcohol and/or drug abuse.
* Positive urine drug screen for illegal or non-prescribed drugs
* Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures.
* Known history of head injury within 6 months of Screening Visit.
* Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated.
* Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or hepatitis C antibody
* Subject is not able or is unwilling to meet the study attendance requirements.
18 Years
75 Years
ALL
No
Sponsors
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Collegium Pharmaceutical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Malamut, MD
Role: STUDY_DIRECTOR
Collegium Pharmaceutical, Inc.
Locations
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Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Anaheim, California, United States
Buena Park, California, United States
Cerritos, California, United States
Escondido, California, United States
La Mesa, California, United States
Napa, California, United States
Pasadena, California, United States
DeLand, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
West Palm Beach, Florida, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
Overland Park, Kansas, United States
Brockton, Massachusetts, United States
Natick, Massachusetts, United States
Watertown, Massachusetts, United States
Pascagoula, Mississippi, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Rapid City, South Dakota, United States
New Tazewell, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Roanoke, Virginia, United States
Bellevue, Washington, United States
Countries
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References
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Katz N, Kopecky EA, O'Connor M, Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458-2467. doi: 10.1097/j.pain.0000000000000315.
Kopecky EA, Vaughn B, Lagasse S, O'Connor M. Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients >/=65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial. Drugs Aging. 2017 Aug;34(8):603-613. doi: 10.1007/s40266-017-0473-7.
Other Identifiers
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CP-OXYDET-08
Identifier Type: -
Identifier Source: org_study_id
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