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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

NCT01571362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2017-04-04

Study results available
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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

Interventions

DRUG

ALO-02

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

DRUG

Placebo

oral placebo, divided into symmetric doses and administered twice daily

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571362 on ClinicalTrials.gov