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Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain

NCT00195728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2011-01-19

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.

Conditions

  • Moderate to Severe Chronic, Non-malignant Pain

Interventions

DRUG

Hydrocodone/Acetaminophen on Extended Release

2 tablets twice daily

Sponsors & Collaborators

Principal Investigators

  • Rita Jain, MD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00195728 on ClinicalTrials.gov