MedTrace Logo

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

NCT01452529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2020-03-10

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Conditions

  • Chronic Low Back Pain

Interventions

DRUG

Hydrocodone bitartrate q24h film-coated tablets

Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

DRUG

Placebo to match hydrocodone bitartrate q24h tablets

Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01452529 on ClinicalTrials.gov