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

Purpose

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.

Condition	Intervention	Phase
Chronic Pain Low Back Pain Analgesia	Drug: ALO-02 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Chronic Pain

Drug Information available for: Oxycodone Oxycodone hydrochloride Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in baseline in daily average pain numerical rating scale scores [ Time Frame: Baseline, weeks 11 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent reduction in daily average pain numerical rating scale scores [ Time Frame: Screening, Weeks 11 and 12 ] [ Designated as safety issue: No ]
Changes in Brief Pain Inventory-Short Form [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Brief Pain Inventory-Short Form [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Brief Pain Inventory-Short Form [ Time Frame: Screening, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Area Under the Curve of the daily average pain numerical rating scale scores [ Time Frame: Screening, Weeks 11 and 12 ] [ Designated as safety issue: No ]
Amount of acetaminophen [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
Time to loss of analgesic response [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Time to treatment discontinuation [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Changes in Roland Morris Disability Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Roland Morris Disability Questionnaire [ Time Frame: Baseline, weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Roland Morris Disability Questionnaire [ Time Frame: Screening, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Patient's Global Assessment of Low Back Pain [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Patient's Global Assessment of Low Back Pain [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Percent of subjects satisfied with treatment [ Time Frame: Randomization, Week 12 ] [ Designated as safety issue: No ]
Changes in Short-Form-36v2 Health Survey [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Short-Form-36v2 Health Survey [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Changes in Short-Form-36v2 Health Survey [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
Changes in EQ-5D Health Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in EQ-5D Health Questionnaire [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Changes in EQ-5D Health Questionnaire [ Time Frame: Screening, Week 12 ] [ Designated as safety issue: No ]
Changes in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Screening, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Healthcare Resource Use Questionnaire [ Time Frame: Screening, Baseline ] [ Designated as safety issue: No ]
Change from baseline in Healthcare Resource Use Questionnaire [ Time Frame: Baseline, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Changes in Healthcare Resource Use Questionnaire [ Time Frame: Screening, Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
mean and median total daily dose of ALO-02 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
percentage of Chronic Low Back Pain Responder Index [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	June 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ALO-02	Drug: ALO-02 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily Other Name: oxycodone HCl and naltrexone HCl
Placebo Comparator: Placebo	Drug: Placebo oral placebo, divided into symmetric doses and administered twice daily Other Name: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571362

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Hide Study Locations

Locations

United States, Alabama
Pfizer Investigational Site	Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site	Recruiting
Goodyear, Arizona, United States, 85395
Pfizer Investigational Site	Recruiting
Phoenix, Arizona, United States, 85023
Pfizer Investigational Site	Recruiting
Phoenix, Arizona, United States, 85027
United States, California
Pfizer Investigational Site	Recruiting
Anaheim, California, United States, 92801
Pfizer Investigational Site	Terminated
Carmichael, California, United States, 95608
Pfizer Investigational Site	Terminated
Fair Oaks, California, United States, 95628
Pfizer Investigational Site	Recruiting
Fresno, California, United States, 93710
Pfizer Investigational Site	Recruiting
Laguna Hills, California, United States, 92637
Pfizer Investigational Site	Recruiting
Long Beach, California, United States, 90806
Pfizer Investigational Site	Recruiting
North Hollywood, California, United States, 91606
United States, Colorado
Pfizer Investigational Site	Recruiting
Colorado Springs, Colorado, United States, 80904
Pfizer Investigational Site	Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
Pfizer Investigational Site	Recruiting
DeLand, Florida, United States, 32720
Pfizer Investigational Site	Recruiting
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site	Recruiting
Plantation, Florida, United States, 33317
Pfizer Investigational Site	Recruiting
Port Orange, Florida, United States, 32129
Pfizer Investigational Site	Recruiting
Tampa, Florida, United States, 33603
Pfizer Investigational Site	Recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site	Recruiting
Marietta, Georgia, United States, 30060
United States, Indiana
Pfizer Investigational Site	Recruiting
Evansville, Indiana, United States, 47714
United States, Maryland
Pfizer Investigational Site	Recruiting
Hollywood, Maryland, United States, 20636
United States, Massachusetts
Pfizer Investigational Site	Recruiting
Worcester, Massachusetts, United States, 01605
United States, Missouri
Pfizer Investigational Site	Recruiting
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site	Recruiting
Omaha, Nebraska, United States, 68134
United States, Nevada
Pfizer Investigational Site	Recruiting
Las Vegas, Nevada, United States, 89144
United States, New Mexico
Pfizer Investigational Site	Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Pfizer Investigational Site	Recruiting
Hartsdale, New York, United States, 10530
Pfizer Investigational Site	Recruiting
New Windsor, New York, United States, 12553
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10022
Pfizer Investigational Site	Recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Pfizer Investigational Site	Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site	Recruiting
Cincinnati, Ohio, United States, 45227
Pfizer Investigational Site	Recruiting
Columbus, Ohio, United States, 43213
United States, Oklahoma
Pfizer Investigational Site	Recruiting
Oklahoma City, Oklahoma, United States, 73112
Pfizer Investigational Site	Recruiting
Oklahoma City, Oklahoma, United States, 73119
United States, Pennsylvania
Pfizer Investigational Site	Recruiting
Altoona, Pennsylvania, United States, 16602
Pfizer Investigational Site	Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
Pfizer Investigational Site	Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Pfizer Investigational Site	Recruiting
Charleston, South Carolina, United States, 29406
Pfizer Investigational Site	Recruiting
Columbia, South Carolina, United States, 29204
United States, Texas
Pfizer Investigational Site	Recruiting
Austin, Texas, United States, 78731
Pfizer Investigational Site	Recruiting
Dallas, Texas, United States, 75231
Pfizer Investigational Site	Recruiting
Dallas, Texas, United States, 75230
Pfizer Investigational Site	Recruiting
San Antonio, Texas, United States, 78229
Pfizer Investigational Site	Recruiting
San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01571362 History of Changes
Other Study ID Numbers:	B4531002, B4531002
Study First Received:	April 3, 2012
Last Updated:	May 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

oxycodone
naltrexone
chronic pain
low back pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naltrexone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013