Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

NCT01685684 | Completed Phase 3 Results

• 1 other identifier: CP-OXYDET-08
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 45

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

  Randomized Baseline through Week 12

Secondary Outcomes (8)

• Time-to-exit From the Study for All Causes

  Randomization Baseline through Week 12

• Percent Reduction in Pain Intensity for Responders

  Screening Baseline through Week 12

• Weekly Changes in Pain Intensity

  Randomization Baseline and weekly through Week 12

• Rescue Medication Usage by Dose

  Randomization Baseline through Week 12

• Rescue Medication Use by Dosage

  Randomization Baseline through Week 12

Study Arms (2)

Oxycodone DETERx

EXPERIMENTAL

Drug: Oxycodone DETERx

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxycodone DETERx DRUG

40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h

Oxycodone DETERx

Placebo DRUG

Placebo, divided into 2 doses, q12h

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Collegium Pharmaceutical, Inc.: lead

Study Sites (45)

Unknown Facility

Mesa, Arizona, 85282, United States

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Phoenix, Arizona, 85050, United States

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Tucson, Arizona, 85704, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Buena Park, California, 90620, United States

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Cerritos, California, 90703, United States

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Escondido, California, 92025, United States

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La Mesa, California, 91942, United States

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Napa, California, 94558, United States

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Pasadena, California, 91105, United States

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DeLand, Florida, 32720, United States

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Naples, Florida, 34108, United States

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Orlando, Florida, 32860, United States

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Plantation, Florida, 33317, United States

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West Palm Beach, Florida, 33409, United States

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Columbus, Georgia, 31904, United States

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Marietta, Georgia, 30060, United States

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Indianapolis, Indiana, 46203, United States

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Valparaiso, Indiana, 46383, United States

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Overland Park, Kansas, 66211, United States

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Brockton, Massachusetts, 02301, United States

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Natick, Massachusetts, 01760, United States

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Watertown, Massachusetts, 02472, United States

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Pascagoula, Mississippi, 39581, United States

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St Louis, Missouri, 63128, United States

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Las Vegas, Nevada, 89123, United States

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Berlin, New Jersey, 08009, United States

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New York, New York, 10128, United States

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Rochester, New York, 14618, United States

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Williamsville, New York, 14221, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45242, United States

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Oklahoma City, Oklahoma, 73116, United States

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Philadelphia, Pennsylvania, 19139, United States

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Charleston, South Carolina, 29406, United States

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Rapid City, South Dakota, 57702, United States

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New Tazewell, Tennessee, 37825, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77098, United States

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Orem, Utah, 84058, United States

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Salt Lake City, Utah, 84106, United States

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Roanoke, Virginia, 24018, United States

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Bellevue, Washington, 98007, United States

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Related Publications (2)

• 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.

  PMID: 26262828 RESULT

• 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.

  PMID: 28600725 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Scientist
• Organization: Collegium Pharmaceutical

clinicaltrials@collegiumpharma.com

+1.781.232.0764

Study Officials

• Richard Malamut, MD

  Collegium Pharmaceutical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 19, 2020
• Results First Posted: February 23, 2017

Record last verified: 2019-02

Locations

US (45)