N/A
N=1,261
Survey of Osteoarthritis Real World Therapies (MK-0663-140)
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01294696 ↗Enrolled (actual)
1,261
Serious AEs
3.0%
Results posted
Mar 2014
Primary outcome: Primary: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline — 46.2; 53.8 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Standard of care for treatment of osteoarthritis (OA) of knee(s) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline |
46.2; 53.8 | — |
| PRIMARY Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 |
47.3; 52.7 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1) |
43.4 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1 |
44.8 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3 |
44.7 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6 |
45.3 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9 |
48.6 | — |
| SECONDARY Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12 |
49.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01294696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.