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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01264965
Other study ID # 10-238-B
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 2011
Est. completion date February 2014

Study information

Verified date November 2020
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. age over 65 2. Pain at least 3 months duration 3. Pain greater in lower extremity than other anatomical site with ambulation 4. Pain self-report of moderate intensity of higher on an average day 5. Community-dwelling 6. Ambulatory 7. Physician states participants have decision-making capacity to enroll into the trial 8. Participants with cognitive impairment have a reliable caregiver 9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past Exclusion Criteria: 1. Current cancer requiring chemotherapy 2. History of addiction to opioids or other controlled substance 3. Consumes more than 2 alcoholic drinks a day 4. Severe balance disturbance 5. Intra-articular steroid injection in the past 6 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
long acting oxycodone
10mg twice daily
extra strength acetaminophen
1,000 mg twice daily

Locations

Country Name City State
United States University of Chicago Medical Center Outpatient Senior Health Center South Shore Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Self-report on the Brief Pain Inventory and WOMAC 14 days
Secondary Discontinuation of Study Drug, Short Physical Performance Battery 14 days
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