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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

This study has been terminated.
(recruitment problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264965
First Posted: December 22, 2010
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 20, 2010
First Posted: December 22, 2010
Last Update Posted: November 14, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Cognitive Dysfunction
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