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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

This study has been terminated.
(recruitment problems)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01264965
First received: December 20, 2010
Last updated: November 12, 2014
Last verified: November 2014
  Purpose
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.

Condition Intervention Phase
Arthritis
Pain
Cognitive Impairment
Drug: long acting oxycodone
Drug: extra strength acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • pain self-report on the brief pain inventory and WOMAC [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • discontinuation of study drug, short physical performance battery [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Drug: extra strength acetaminophen
1,000 mg twice daily
Active Comparator: Long Acting Oxycodone Drug: long acting oxycodone
10mg twice daily

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264965

Locations
United States, Illinois
University of Chicago Medical Center Outpatient Senior Health Center South Shore
Chicago, Illinois, United States, 60649
Sponsors and Collaborators
University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01264965     History of Changes
Other Study ID Numbers: 10-238-B 
Study First Received: December 20, 2010
Last Updated: November 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Pain
Analgesia
Cognitive impairment
Randomized controlled trial
Physical function

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Acetaminophen
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on December 07, 2016