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A Study of Pain Relief in Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00298974
First received: March 2, 2006
Last updated: January 24, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis
 Drug: hydrocodone / acetaminophen extended release
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)


Secondary Outcome Measures:
  • Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF-36v2 Health Status Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 873
Study Start Date: February 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298974

  Show 83 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, M.D. Abbott
  More Information

No publications provided

Responsible Party: Earle Lockhart,MD, Abbott
ClinicalTrials.gov Identifier: NCT00298974     History of Changes
Other Study ID Numbers: M04-697
Study First Received: March 2, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Osteoarthritis of the hip or knee

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

ClinicalTrials.gov processed this record on May 16, 2013