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

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

A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain

NCT01571362•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (52)

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Dedicated Clinical Research

Goodyear, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Premier Research Group Limited

Phoenix, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Med Center

Carmichael, California, United States

Med Investigations, Inc.

Fair Oaks, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Pacific Coast Pain Management Center

Laguna Hills, California, United States

Long Beach Center for Clinical Research - previous addresse

Long Beach, California, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

April 4, 2017

Enrollment

410

ACTUAL participants

Conditions

Chronic PainLow Back PainAnalgesia

Interventions

ALO-02

DRUG

Placebo

DRUG

Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children

NCT07242196

Postoperative AnalgesiaTransversus Abdominis Plane (TAP) Block+3 more

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RECRUITING

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

NCT06661850

Discogenic Low Back Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Optimization of NIBS for Treatment of Addiction

Time to BBVNA Relief

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