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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195728
First received: September 13, 2005
Last updated: January 17, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Chronic, Non-malignant Pain
Drug: Hydrocodone/Acetaminophen on Extended Release
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety evaluation [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    Long term safety


Enrollment: 431
Study Start Date: June 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydrocodone/acetaminophen extended release Drug: Hydrocodone/Acetaminophen on Extended Release
2 tablets twice daily
Other Name: ABT-712

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females between 21 and 75 years of age

    • 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:

  • Pregnant and/or breastfeeding females or females planning to become pregnant during the course of the study
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195728

  Show 76 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

Responsible Party: Andrea Best, DO, MPH, Abbott
ClinicalTrials.gov Identifier: NCT00195728     History of Changes
Other Study ID Numbers: M03-666
Study First Received: September 13, 2005
Last Updated: January 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hydrocodone/Acetaminophen
Vicodin CR

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014