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Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

NCT01685684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2020-10-19

Study results available
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Summary

The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.

Conditions

  • Chronic Low Back Pain

Interventions

DRUG

Oxycodone DETERx

40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h

DRUG

Placebo

Placebo, divided into 2 doses, q12h

Sponsors & Collaborators

  • Collegium Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Malamut, MD · Collegium Pharmaceutical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01685684 on ClinicalTrials.gov