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A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00404183
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Abbott

Brief Summary:
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.

Condition or disease Intervention/treatment Phase
Pain Drug: Extended-Release Hydrocodone/Acetaminophen Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis
Study Start Date : August 2004
Actual Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: hydrocodone/acetaminophen extended release Drug: Extended-Release Hydrocodone/Acetaminophen
2 tablets BID
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release

Placebo Comparator: Placebo Drug: Placebo
2 tablets BID




Primary Outcome Measures :
  1. Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable"). [ Time Frame: 4 weeks ]
    Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)


Secondary Outcome Measures :
  1. WOMAC Osteoarthritis Index, SF36 [ Time Frame: 4 weeks ]
    Osteoarthritis Index



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ages 21 to 75
  • Has osteoarthritis of the hip or knee
  • Requires therapeutic doses of medications for osteoarthritis
  • If female, must be of non-childbearing potential or practicing birth control
  • Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

  • Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
  • Has certain medical conditions which may interfere with pain assessments
  • Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
  • Has had certain infections, injuries or illnesses within the last month
  • Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
  • Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
  • Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
  • Cannot discontinue pain medications, even for a short time, prior to the study start

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404183


Sponsors and Collaborators
Abbott
Investigators
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Study Director: Rita Jain, MD Abbott

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Responsible Party: Victor Jorden, MD, Abbott
ClinicalTrials.gov Identifier: NCT00404183     History of Changes
Other Study ID Numbers: M03-643
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by Abbott:
Pain associated with osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents