AzTrials
AzTrials

Chronic Low Back PainPhase 3NCT01685684

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

A Phase 3 study testing Oxycodone DETERx in people with Chronic Low Back Pain, run by Collegium Pharmaceutical, Inc. at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Oxycodone DETERx
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
740 participants
Where
45 sitesUnited States
Study dates
Aug 2012to Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Anaheim, California, 92804

  • Study site

    Austin, Texas, 78731

  • Study site

    Bellevue, Washington, 98007

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Buena Park, California, 90620

  • Study site

    Cerritos, California, 90703

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Dallas, Texas, 75230

  • Study site

    DeLand, Florida, 32720

  • Study site

    Escondido, California, 92025

  • Study site

    Houston, Texas, 77098

  • Study site

    Indianapolis, Indiana, 46203

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mesa, Arizona, 85282

  • Study site

    Napa, California, 94558

  • Study site

    Naples, Florida, 34108

  • Study site

    Natick, Massachusetts, 01760

  • Study site

    New Tazewell, Tennessee, 37825

  • Study site

    New York, New York, 10128

  • Study site

    Oklahoma City, Oklahoma, 73116

  • Study site

    Orem, Utah, 84058

  • Study site

    Orlando, Florida, 32860

  • Study site

    Overland Park, Kansas, 66211

  • Study site

    Pasadena, California, 91105

  • Study site

    Pascagoula, Mississippi, 39581

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Plantation, Florida, 33317

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Roanoke, Virginia, 24018

  • Study site

    Rochester, New York, 14618

  • Study site

    Salt Lake City, Utah, 84106

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Valparaiso, Indiana, 46383

  • Study site

    Watertown, Massachusetts, 02472

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Williamsville, New York, 14221

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Being tested
Oxycodone DETERx, Placebo
Keywords
Low back pain, Chronic back pain, Back pain, Opioid, Oxycodone, DETERx, Chronic pain, Chronic low back pain, CLBP, Xtampza
Medical subject headings
Low Back Pain, Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone DETERxDrug

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

  • PlaceboDrug

    Placebo, divided into 2 doses, q12h

Study groups in NCT01685684
Study groupRoleWhat they receive
Oxycodone DETERxExperimentalNot described
Receives: Drug: Oxycodone DETERx
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Randomized Baseline through Week 12

Secondary outcomes (8)

  1. Time-to-exit From the Study for All Causes

    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.

    Measured: Randomization Baseline through Week 12

  2. Percent Reduction in Pain Intensity for Responders

    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.

    Measured: Screening Baseline through Week 12

  3. Weekly Changes in Pain Intensity

    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).

    Measured: Randomization Baseline and weekly through Week 12

  4. Rescue Medication Usage by Dose

    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)

    Measured: Randomization Baseline through Week 12

  5. Rescue Medication Use by Dosage

    Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)

    Measured: Randomization Baseline through Week 12

  6. Patient Global Impression of Change (PGIC)

    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".

    Measured: Screening Baseline through Week 12

  7. Changes in Quality of Life

    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.

    Measured: Randomization Baseline through Week 12

  8. Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)

    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.

    Measured: Randomization Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685684
Sponsor's protocol ID
CP-OXYDET-08
Status last verified
Feb 2019
First submitted
12 Sep 2012
Last updated
19 Oct 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 26262828

  • 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.

    PubMed 28600725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone DETERx in people with Chronic Low Back Pain, run by Collegium Pharmaceutical, Inc. at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Randomized Baseline through Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685684, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in