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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01685684
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : February 23, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Collegium Pharmaceutical, Inc.

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 14, 2012
Results First Submitted Date  ICMJE May 25, 2016
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Drug: Oxycodone DETERx
    40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
  • Drug: Placebo
    Placebo, divided into 2 doses, q12h
Study Arms  ICMJE
  • Experimental: Oxycodone DETERx
    Intervention: Drug: Oxycodone DETERx
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
740
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
350
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685684
Other Study ID Numbers  ICMJE CP-OXYDET-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Collegium Pharmaceutical, Inc.
Study Sponsor  ICMJE Collegium Pharmaceutical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Diana Meske, PhD Collegium Pharmaceutical, Inc.
PRS Account Collegium Pharmaceutical, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP