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Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

NCT01081912 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2022-12-08

Study results available
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Summary

The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

Conditions

  • Back Pain Lower Back Chronic

Interventions

DRUG

Placebo

Capsules, no active substance, shells identical to active comparator capsules

DRUG

Hydrocodone bitartrate

dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin Romanko, DPM · Zogenix, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01081912 on ClinicalTrials.gov