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A Study of Pain Relief in 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: NCT00298974
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: hydrocodone / acetaminophen extended release Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 873 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis
Study Start Date : February 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: hydrocodone/acetaminophen extended release Drug: hydrocodone / acetaminophen extended release
2 tablets twice daily
Other Name: ABT-712
Placebo Comparator: Placebo Drug: Placebo
2 tablets twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 12 weeks ]
    Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ]
  2. Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ]
  3. SF-36v2 Health Status Survey [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ages 21 to 80
  • If female, must be of non-child bearing potential or practicing birth control
  • Has osteoarthritis of the hip or knee
  • Requires therapeutic doses of medication for osteoarthritis pain
  • Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

  • Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
  • Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
  • Cannot discontinue pain medications, even for the short time prior to the study start
  • Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
  • Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
  • Has a history of malnutrition or starvation
  • Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
  • Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
  • Pregnant or breastfeeding females
  • Is incapacitated, bedridden or confined to a wheelchair
  • Has initiated any new therapy or medication for OA within 1 month of screening
  • Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
  • Has other conditions that may cause pain, such as rheumatoid arthritis or gout
Contacts and Locations
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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): NCT00298974


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Rita Jain, M.D. Abbott
More Information
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Responsible Party: Earle Lockhart,MD, Abbott
ClinicalTrials.gov Identifier: NCT00298974    
Other Study ID Numbers: M04-697
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011
Keywords provided by Abbott:
Osteoarthritis of the hip or knee
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
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