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

Collegium Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Chronic Low Back Pain

Treatments

Drug: Placebo

Drug: Oxycodone DETERx

Study type

Interventional

Funder types

Industry

Identifiers

NCT01685684

CP-OXYDET-08

Details and patient eligibility

About

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.

Enrollment

740 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.