Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
NCT ID: NCT00195728
Last Updated: 2011-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
431 participants
INTERVENTIONAL
2005-06-30
2006-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Pain Relief in Low Back Pain
NCT00325949
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
NCT00763321
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
NCT01922739
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
NCT00761150
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
NCT01081912
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
hydrocodone/acetaminophen extended release
Hydrocodone/Acetaminophen on Extended Release
2 tablets twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydrocodone/Acetaminophen on Extended Release
2 tablets twice daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Females must be of non-child bearing potential or practicing birth control
* Moderate to severe mechanical low back pain OR moderate to severe OA of the hip or knee pain
* Require medicine for pain the majority of days in the previous 3 months, AND for at least 4 days per week, during the previous 4 weeks.
* Pain is not controlled with non-opioid analgesics or is contraindicated due to side effects and/or currently receiving opioid therapy equivalent to 40 mg/day of morphine or less
Exclusion Criteria
* Incapacitated, bedridden, or confined to a wheelchair permitting little or no self-care
* Injury to the index joint or lower back within 3 months of study
* History of any of the following:
* Major surgery to the lower back within the last 5 years OR
* Joint replacement/reconstruction to the index joint OR
* Arthroscopic or open surgery to the index joint within the last year OR
* Any surgery within 3 months of study
* Osteoporotic compression fracture, traumatic vertebral fracture or invasive intervention for low back pain within the last year.
* Abnormal neurological exam, or lower extremity symptoms characteristic of neurogenic pain
* History of inflammatory or infectious arthritis, tumors or infections of spinal cord, spinal stenosis, fibromyalgia or other chronic painful condition
* Severe gastrointestinal narrowing
* History of peritonitis, cystic fibrosis, chronic intestinal eudoobstruction, or Meckel's diverticulum.
* Has received
* Oral, intramuscular (IM), intravenous (IV) or non-index joint intra- articular corticosteroids within 1 month of study OR
* Intra-articular corticosteroids at the index joint or epidural corticosteroids to the lower back region within 2 months of study, OR
* Viscosupplementation therapy to index joint within 4 months of study
* History of drug (licit or illicit) or alcohol abuse/addiction
* Positive result for drugs of abuse at screening.
* Chronic heavy drinker, consuming more than 4 alcoholic drinks per day.
* History of malnutrition or starvation or is likely to fast for more than 4 consecutive days during the course of the study.
* Medical condition or illness other than OA/CLBP, which is not well controlled
* History of allergic reaction or a clinically significant sensitivity or intolerance to opioids and/or acetaminophen.
* Newly diagnosed medical condition
* Clinically significant infection/injury/illness within 1 month of study
* Receiving systemic chemotherapy, or has an active malignancy of any type, or has been diagnosed with cancer within the past 5 years. Basal cell carcinoma of the skin that has been successfully treated will be permitted.
* Known or suspected history of Human Immunodeficiency Virus.
* Positive Hepatitis Screen
* Clinically significant abnormalities in clinical chemistry, hematology or urinalysis
* Received any investigational drug within 1 month of study
* History of major psychiatric disorder
* Active or uncontrolled seizure disorder.
* Requires treatment with monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants during the course of the study.
* Surgical procedure planned, or scheduled during the course of this study.
* Ongoing workman's compensation claim or litigation.
* Previous participation in the M03-666 study.
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abbott
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rita Jain, MD
Role: STUDY_DIRECTOR
Abbott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site Ref # / Investigator 1696
Huntsville, Alabama, United States
Site Reference # / Investigator 1729
Chandler, Arizona, United States
Site Reference # / Investigator 1702
Mesa, Arizona, United States
Site Reference # / Investigator 1745
Peoria, Arizona, United States
Site Ref # / Investigator 1697
Tempe, Arizona, United States
Site Ref # / Investigator 1818
Tempe, Arizona, United States
Site Reference # / Investigator 1795
Tucson, Arizona, United States
Site Ref # / Investigator 2555
Carmichael, California, United States
Site Reference # / Investigator 1688
Fair Oaks, California, United States
Site Reference # / Investigator 1790
Pasadena, California, United States
Site Reference # / Investigator 1735
San Diego, California, United States
Site Reference # / Investigator 1775
San Luis Obispo, California, United States
Site Ref # / Investigator 1742
Santa Ana, California, United States
Site Ref # / Investigator 1754
Tarzana, California, United States
Site Reference # / Investigator 1700
Whittier, California, United States
Site Reference # / Investigator 1690
Colorado Springs, Colorado, United States
Site Ref # / Investigator 1713
Littleton, Colorado, United States
Site Ref # / Investigator 1711
Bristol, Connecticut, United States
Site Reference # / Investigator 1723
Clearwater, Florida, United States
Site Ref # / Investigator 1813
Clearwater, Florida, United States
Site Reference # / Investigator 1718
DeLand, Florida, United States
Site Reference # / Investigator 1819
Longwood, Florida, United States
Site Reference # / Investigator 1809
Miami, Florida, United States
Site Reference # / Investigator 1738
Miami, Florida, United States
Site Ref # / Investigator 1716
Orlando, Florida, United States
Site Reference # / Investigator 1755
Palm Harbor, Florida, United States
Site Ref # / Investigator 1814
Pembroke Pines, Florida, United States
Site Reference # / Investigator 1737
Plantation, Florida, United States
Site Reference # / Investigator 1747
St. Petersburg, Florida, United States
Site Reference # / Investigator 1744
Arlington Heights, Illinois, United States
Site Reference # / Investigator 1691
Chicago, Illinois, United States
Site Reference # / Investigator 1714
Evansville, Indiana, United States
Site Ref # / Investigator 1739
Metairie, Louisiana, United States
Site Reference # / Investigator 1810
Owings Mills, Maryland, United States
Site Ref # / Investigator 1707
Fall River, Massachusetts, United States
Site Reference # / Investigator 1743
Wellesley Hills, Massachusetts, United States
Site Ref # / Investigator 1792
Jackson, Mississippi, United States
Site Reference # / Investigator 1721
St Louis, Missouri, United States
Site Ref # / Investigator 1812
St Louis, Missouri, United States
Site Reference # / Investigator 2424
St Louis, Missouri, United States
Site Ref # / Investigator 1722
Omaha, Nebraska, United States
Site Ref # / Investigator 1774
Omaha, Nebraska, United States
Site Reference # / Investigator 1789
Omaha, Nebraska, United States
Site Reference # / Investigator 1705
Las Vegas, Nevada, United States
Site Reference # / Investigator 1791
Las Vegas, Nevada, United States
Site Reference # / Investigator 1701
Medford, New Jersey, United States
Site Reference # / Investigator 2461
Trenton, New Jersey, United States
Site Reference # / Investigator 1726
Binghamton, New York, United States
Site Reference # / Investigator 1815
New York, New York, United States
Site Reference # / Investigator 1708
Charlotte, North Carolina, United States
Site Ref # / Investigator 1730
Monroe, North Carolina, United States
Site Reference # / Investigator 1741
Raleigh, North Carolina, United States
Site Reference # / Investigator 1689
Cincinnati, Ohio, United States
Site Ref # / Investigator 1694
Cincinnati, Ohio, United States
Site Ref # / Investigator 1816
Cleveland, Ohio, United States
Site Reference # / Investigator 1715
Oklahoma City, Oklahoma, United States
Site Reference # / Investigator 2423
Portland, Oregon, United States
Site Reference # / Investigator 1794
Beaver, Pennsylvania, United States
Site Reference # / Investigator 1749
Duncansville, Pennsylvania, United States
Site Reference # / Investigator 1752
Erie, Pennsylvania, United States
Site Reference # / Investigator 1709
Mechanicsburg, Pennsylvania, United States
Site Reference # / Investigator 1757
Cordova, Tennessee, United States
Site Reference # / Investigator 1727
Selmer, Tennessee, United States
Site Ref # / Investigator 1692
Austin, Texas, United States
Site Reference # / Investigator 1722
Austin, Texas, United States
Site Reference # / Investigator 2425
Dallas, Texas, United States
Site Reference # / Investigator 1699
Fort Worth, Texas, United States
Site Ref # / Investigator 1725
Killeen, Texas, United States
Site Reference # / Investigator 1710
San Angelo, Texas, United States
Site Reference # / Investigator 1686
San Antonio, Texas, United States
Site Reference # / Investigator 2426
San Antonio, Texas, United States
Site Reference # / Investigator 1808
San Antonio, Texas, United States
Site Reference # / Investigator 1732
Salt Lake City, Utah, United States
Site Reference # / Investigator 1740
Salt Lake City, Utah, United States
Site Ref # / Investigator 1733
Norfolk, Virginia, United States
Site Reference # / Investigator 1719
Virginia Beach, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M03-666
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.