Survey of Osteoarthritis Real World Therapies (MK-0663-140)

NCT01294696 | Completed Results

• 1 other identifier: 0663-140
• Study Type: observational
• Target: 1,261
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Standard of care

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline

  Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).

  Baseline (Day 1)

• Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12

  Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).

  Month 12

Secondary Outcomes (6)

• Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)

  Baseline (Day 1)

• Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1

  Month 1

• Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3

  Month 3

• Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6

  Month 6

• Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9

  Month 9

Study Arms (1)

All Enrolled Participants

All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.

Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)

Interventions

Standard of care for treatment of osteoarthritis (OA) of knee(s) DRUG

All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.

All Enrolled Participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 25150513 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Vice President, Late Stage Group Development Leader
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: February 11, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 29, 2024
• Results First Posted: March 4, 2014

Record last verified: 2022-02