Trial Outcomes & Findings for Non-cancer Pain and Cognitive Impairment: A Disabling Relationship (NCT NCT01264965)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

14 days

Results posted on

2020-12-11

Participant milestones
Measure	All Enrolled Patients This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
Overall Study STARTED	25
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	10

Reasons for withdrawal
Measure	All Enrolled Patients This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
Overall Study Withdrawal by Subject	10

Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

Baseline characteristics by cohort
Measure	All Enrolled Patients n=25 Participants This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
Age, Continuous	79.4 years n=113 Participants
Sex: Female, Male Female	22 Participants n=113 Participants
Sex: Female, Male Male	3 Participants n=113 Participants
Region of Enrollment United States	25 participants n=113 Participants

Timeframe: 14 days

Population: No data are available for this outcome (study records were lost).

Outcome data not reported

Timeframe: 14 days

Population: No data are available for this outcome (study records were lost).

Outcome data not reported

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Enrolled Patients n=25 participants at risk This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to.
Gastrointestinal disorders Nausea	36.0% 9/25 This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to. In addition, no information is available on the timing of adverse events. As a result, adverse events can only be reported for the entire group of enrolled patients.
Psychiatric disorders Confusion	8.0% 2/25 This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to. In addition, no information is available on the timing of adverse events. As a result, adverse events can only be reported for the entire group of enrolled patients.

University of Chicago

Phone: 773-702-9326