Clinical trial NCT01294696: Survey of Osteoarthritis Real World Therapies (MK-0663-140)
Official title: Survey of Osteoarthritis Real World Therapies (SORT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Standard of care
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 1261
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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 pain level over a 12-month follow-up period.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
timeFrame: Baseline (Day 1)
measure: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)
timeFrame: Baseline (Day 1)
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1
timeFrame: Month 1
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3
timeFrame: Month 3
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6
timeFrame: Month 6
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9
timeFrame: Month 9
measure: Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
Study officials:
References:
citation: Conaghan PG, Peloso PM, Everett SV, Rajagopalan S, Black CM, Mavros P, Arden NK, Phillips CJ, Rannou F, van de Laar MA, Moore RA, Taylor SD. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford). 2015 Feb;54(2):270-7. doi: 10.1093/rheumatology/keu332. Epub 2014 Aug 23.