A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Pfizer

Status and phase

Completed

Phase 3

Conditions

Chronic Pain

Analgesia

Low Back Pain

Treatments

Drug: Placebo

Drug: ALO-02

Study type

Interventional

Funder types

Industry

Identifiers

NCT01571362

B4531002

ALO-02-10-3002 (Other Identifier)

Details and patient eligibility

About

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Enrollment

410 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Moderate-to-severe chronic low back pain present for at least 3 months.
Require a continuous around-the-clock opioid analgesic for an extended period of time.
Refrain from taking other opioid and non-opioid medications during the study.

Exclusion criteria

Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
Active or ongoing or history of alcohol or drug abuse.