Clinical trial NCT01685684: Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
Official title: A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: Low back pain
Chronic back pain
Back pain
Opioid
Oxycodone
DETERx
Chronic pain
Chronic low back pain
CLBP
Xtampza
Lead sponsor: Collegium Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-14
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent.
* 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:

* Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy.
* 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.

Other protocol specific inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
timeFrame: Randomized Baseline through Week 12
Secondary outcomes:
measure: Time-to-exit From the Study for All Causes
timeFrame: Randomization Baseline through Week 12
measure: Percent Reduction in Pain Intensity for Responders
timeFrame: Screening Baseline through Week 12
measure: Weekly Changes in Pain Intensity
timeFrame: Randomization Baseline and weekly through Week 12
measure: Rescue Medication Usage by Dose
timeFrame: Randomization Baseline through Week 12
measure: Rescue Medication Use by Dosage
timeFrame: Randomization Baseline through Week 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: Screening Baseline through Week 12
measure: Changes in Quality of Life
timeFrame: Randomization Baseline through Week 12
measure: Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Randomization Baseline and Week 12
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Escondido
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Napa
country: United States
state: California
city: Pasadena
country: United States
state: California
city: DeLand
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Brockton
country: United States
state: Massachusetts
city: Natick
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: Pascagoula
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: New Tazewell
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
Study officials:
affiliation: Collegium Pharmaceutical, Inc.
name: Richard Malamut, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.