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

NCT01571362 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: B4531002ALO-02-10-3002
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Chronic Pain; Low Back Pain; Analgesia

Keywords

oxycodone; naltrexone; chronic pain; low back pain

Outcome Measures

Primary Outcomes (1)

• Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)

  Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

  Weeks 11 and 12

Secondary Outcomes (100)

• Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).

  Week 12

• Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).

  Randomization Baseline, Week 12

• Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%

  Weeks 11 and 12

• Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%

  Weeks 11 and 12

• Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%

  Weeks 11 and 12

Study Arms (2)

ALO-02

EXPERIMENTAL

Drug: ALO-02

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALO-02 DRUG

20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily

Also known as: oxycodone HCl and naltrexone HCl

ALO-02

Placebo DRUG

oral placebo, divided into symmetric doses and administered twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Dedicated Clinical Research

Goodyear, Arizona, 85395, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Premier Research Group Limited

Phoenix, Arizona, 85027, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Med Center

Carmichael, California, 95608, United States

Location

Med Investigations, Inc.

Fair Oaks, California, 95628, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Pacific Coast Pain Management Center

Laguna Hills, California, 92637, United States

Location

Long Beach Center for Clinical Research - previous addresse

Long Beach, California, 90806, United States

Location

Long Beach Center for Clinical Research

Long Beach, California, 90807, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Clinicos, LLC

Colorado Springs, Colorado, 80904, United States

Location

Lynn Institute of the Rockies Medical Centre

Colorado Springs, Colorado, 80907, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Ormond Medical Arts pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Gold Coast Research, LLC

Plantation, Florida, 33317, United States

Location

The Office of Martin E. Hale, MD, PA

Plantation, Florida, 33317, United States

Location

Accord Clinical Research, LLC- Duplicate 2

Port Orange, Florida, 32129, United States

Location

Accord Clinical Research, LLC- Duplicate

Port Orange, Florida, 32129, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, 30060, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Mid-Atlantic Medical Research - Research Department

Hollywood, Maryland, 20636, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Heartland Clinical Research, Inc.

Omaha, Nebraska, 68134, United States

Location

Office of Stephen H. Miller, M.D.

Las Vegas, Nevada, 89144, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Mid Hudson Medical Research, PLLC

New Windsor, New York, 12553, United States

Location

Research Across America

New York, New York, 10022, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Columbus Clinical Research

Columbus, Ohio, 43213, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Associated Orthopedics

Oklahoma City, Oklahoma, 73119, United States

Location

Hillcrest Clinical Research

Oklahoma City, Oklahoma, 73119, United States

Location

Allegheny Pain Management, PC

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Pain Research of Charleston

Charleston, South Carolina, 29406, United States

Location

TLM Medical Services

Columbia, South Carolina, 29204, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Lee Medical Associates

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research, P.A.

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

• Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.

  PMID: 31849032 DERIVED

• Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.

  PMID: 31456431 DERIVED

• Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.

  PMID: 29041942 DERIVED

• Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.

  PMID: 25993547 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Agnosia

Interventions

oxycodone naltrexone combination; Oxycodone; Naltrexone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (52)