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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Collegium Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01685684
First received: September 12, 2012
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase [ Time Frame: Randomized Baseline through Week 12 ]
    The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures:
  • Time-to-exit From the Study for All Causes [ Time Frame: Randomization Baseline through Week 12 ]
    Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.

  • Percent Reduction in Pain Intensity for Responders [ Time Frame: Screening Baseline through Week 12 ]
    Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.

  • Weekly Changes in Pain Intensity [ Time Frame: Randomization Baseline and weekly through Week 12 ]
    Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).

  • Rescue Medication Usage by Dose [ Time Frame: Randomization Baseline through Week 12 ]
    Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)

  • Rescue Medication Use by Dosage [ Time Frame: Randomization Baseline through Week 12 ]
    Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)

  • Patient Global Impression of Change (PGIC) [ Time Frame: Screening Baseline through Week 12 ]
    The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse".

  • Changes in Quality of Life [ Time Frame: Randomization Baseline through Week 12 ]
    Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.

  • Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Randomization Baseline and Week 12 ]
    The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.


Enrollment: 740
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  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

  Show 45 Study Locations
Sponsors and Collaborators
Collegium Pharmaceutical, Inc.
Investigators
Study Director: Ernest A. Kopecky, PhD, MBA Collegium Pharmaceutical, Inc.
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: May 25, 2016
Last Updated: January 3, 2017

Keywords provided by Collegium Pharmaceutical, Inc.:
Low back pain
Chronic back pain
Back pain
Opioid
Oxycodone
DETERx
Chronic pain
Chronic low back pain
CLBP
Xtampza

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

ClinicalTrials.gov processed this record on June 26, 2017