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NCT01571362 Clinical Trial

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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01571362
Other study ID # B4531002
Secondary ID B4531002
Status Completed
Phase Phase 3
First received April 3, 2012
Last updated August 4, 2014
Start date June 2012
Est. completion date June 2013

Study information
Verified date August 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ALO-02
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
• Placebo
oral placebo, divided into symmetric doses and administered twice daily

Locations
Country Name City State
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Altoona Pennsylvania
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Carmichael California
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Duncansville Pennsylvania
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fair Oaks California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Goodyear Arizona
United States Pfizer Investigational Site Hartsdale New York
United States Pfizer Investigational Site Hollywood Maryland
United States Pfizer Investigational Site Laguna Hills California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site New Windsor New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site North Hollywood California
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Ormond Beach Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Port Orange Florida
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Warwick Rhode Island
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Williamsville New York
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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