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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collegium Pharmaceutical, Inc.
• Treatments: Oxycodone

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.