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
  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:


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
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: 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
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 October 16, 2014