Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

NCT01264965 | Terminated Phase 4 Results

• 1 other identifier: 10-238-B
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis; Pain; Cognitive Impairment

Keywords

Pain; Analgesia; Cognitive impairment; Randomized controlled trial; Physical function

Outcome Measures

Primary Outcomes (1)

• Pain Self-report on the Brief Pain Inventory and WOMAC

  14 days

Secondary Outcomes (1)

• Discontinuation of Study Drug, Short Physical Performance Battery

  14 days

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Drug: extra strength acetaminophen

Long Acting Oxycodone

ACTIVE COMPARATOR

Drug: long acting oxycodone

Interventions

long acting oxycodone DRUG

10mg twice daily

Long Acting Oxycodone

extra strength acetaminophen DRUG

1,000 mg twice daily

Acetaminophen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age over 65
• Pain at least 3 months duration
• Pain greater in lower extremity than other anatomical site with ambulation
• Pain self-report of moderate intensity of higher on an average day
• Community-dwelling
• Ambulatory
• Physician states participants have decision-making capacity to enroll into the trial
• Participants with cognitive impairment have a reliable caregiver
• Inadequate pain relief from NSAIDS and/or acetaminophen in the past

You may not qualify if:

• Current cancer requiring chemotherapy
• History of addiction to opioids or other controlled substance
• Consumes more than 2 alcoholic drinks a day
• Severe balance disturbance
• Intra-articular steroid injection in the past 6 weeks

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center Outpatient Senior Health Center South Shore

Chicago, Illinois, 60649, United States

Location

MeSH Terms

Conditions

Arthritis; Pain; Cognitive Dysfunction; Agnosia

Interventions

acetaminophen, aspirin, caffeine drug combination

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Theodore Karrison
• Organization: University of Chicago

karr@health.bsd.uchicago.edu

773-702-9326

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2020-11

Locations

US (1)