Survey of the Relief of Symptoms of Osteoarthritis of the Knee According to Standard Medical Guidelines or Clinical Practice Standards (MK-0663-140) - Full Text View

Purpose

This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their history, clinical care and health outcomes over a 12-month follow-up period.

Condition	Intervention
Osteoarthritis	Drug: Standard of care for treatment of OA of knee(s)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Survey of Osteoarthritis Real World Therapies (SORT)

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Estimation of the proportion of subjects who report adequate vs. inadequate pain relief at baseline as measured by the Brief Pain Inventory [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
Estimation of the proportion of patients with and without inadequate pain relief at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Baseline (Day 1) [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
Estimate the proportion of patients who report adequate relief from joint stiffness or limitation in physical function as defined by Western Ontario McMaster University Osteoarthritis Index (WOMAC) scores at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment:	1254
Study Start Date:	October 2010
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All enrolled participants	Drug: Standard of care for treatment of OA of knee(s) All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants who are presently receiving prescribed oral or topical analgesics which commenced at least two weeks prior to enrollment

Criteria

Inclusion Criteria:

Clinical diagnosis of primary osteoarthritis of the knee(s)
Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment

Exclusion Criteria:

Arthritis other than primary osteoarthritis
Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
Subtotal or total joint replacement in the affected knee
Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01294696 History of Changes
Other Study ID Numbers:	MK-0663-140, GHO-BRID-ACX-01-2010
Study First Received:	December 22, 2010
Last Updated:	February 20, 2013
Health Authority:	Italy: National Observation for Clinical Trials

Keywords provided by Merck:

Osteoarthritis
Standard of care

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Survey of the Relief of Symptoms of Osteoarthritis of the Knee According to Standard Medical Guidelines or Clinical Practice Standards (MK-0663-140) (SORT)