Oxycodone DETERx™ Versus Placebo in CLBP

This study has been completed.
Information provided by (Responsible Party):
Collegium Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
First received: September 12, 2012
Last updated: May 22, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Chronic Low Back Pain
Drug: Oxycodone DETERx
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Collegium Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Change in average pain intensity measured by the change in PI-NRS scores from Randomization Baseline to Week 12 of the Double-blind Maintenance Phase [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in quality of life (SF-12v2) [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Level of physical disability using the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Total amount of rescue medication used [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
    Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, mg per day, total amount used in mg)

  • Time-to-exit from the study for all causes [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percent reduction in pain intensity for responders [ Time Frame: Screening Baseline, Week 12 ] [ Designated as safety issue: No ]
    Includes the cumulative distribution of subjects with an improvement in pain intensity and the proportion of responders with at least 30% and at least a 50% reduction in pain intensity

  • Weekly changes in pain intensity [ Time Frame: Randomization Baseline, Week 12 ] [ Designated as safety issue: No ]
    Based on daily pain intensity scores averaged to weekly scores

  • Safety and tolerability of Oxycodone DETERx compared to placebo, measured by the incidence of treatment-emergent adverse events (TEAEs) and safety parameters including vital signs, hematologic, biochemical, urinalysis, and opioid withdrawal are assessed. [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The incidence of treatment-emergent adverse events (TEAEs) and safety parameters including vital signs, hematologic, biochemical, urinalysis, and opioid withdrawal are assessed.

Enrollment: 389
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone DETERx Drug: Oxycodone DETERx
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
Placebo Comparator: Placebo Drug: Placebo
Placebo, divided into 2 doses, q12h


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685684

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Sponsors and Collaborators
Collegium Pharmaceutical, Inc.
Study Director: Ernest A. Kopecky, PhD, MBA Collegium Pharmaceutical, Inc.
  More Information

Responsible Party: Collegium Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT01685684     History of Changes
Other Study ID Numbers: CP-OXYDET-08 
Study First Received: September 12, 2012
Last Updated: May 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Collegium Pharmaceutical, Inc.:
Low back pain
Chronic back pain
Back pain
Chronic pain
Chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 30, 2016