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

March 2, 2006
January 24, 2011
February 2006
May 2007   (final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
The mean absolute pain intensity difference from baseline to each subject’s Week 12 evaluation
Complete list of historical versions of study NCT00298974 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pain intensity difference from baseline to each scheduled evaluation
  • Proportion of treatment responders
  • Global assessments of study drug and arthritis status
  • Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score and 3 subscales
  • SF-36v2 Health Status Survey
Not Provided
Not Provided
 
A Study of Pain Relief in Osteoarthritis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
  • Drug: hydrocodone / acetaminophen extended release
    2 tablets twice daily
    Other Name: ABT-712
  • Drug: Placebo
    2 tablets twice daily
    Other Name: Placebo
  • Experimental: hydrocodone/acetaminophen extended release
    Intervention: Drug: hydrocodone / acetaminophen extended release
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
873
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298974
M04-697
No
Earle Lockhart,MD, Abbott
Abbott
Not Provided
Study Director: Rita Jain, M.D. Abbott
Abbott
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP