Trial Outcomes & Findings for Open-Label Trial Comparing Oxycodone Medications (NCT NCT01162304)

Last Updated: 2015-07-17

Results Overview

The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p \< 0.05 level using a two-tailed test.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

Daily

Results posted on

2015-07-17

Participant Flow

1-20-2010 to 11-21-2013 at the medical center.

Study was terminated participants were enrolled but treatment arm assigment was not shared with the study team.The study team was blinded and research pharmacy which was tracking randomization destroyed study records before sharing with the study team.

Participant milestones

Participant milestones
Measure	ER Oxycodone vs IR Oxycodone Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life. Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
Overall Study STARTED	18
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	ER Oxycodone vs IR Oxycodone Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life. Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
Overall Study Beck scale to high	11

Baseline Characteristics

Open-Label Trial Comparing Oxycodone Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ER Oxycodone vs IR Oxycodone n=18 Participants Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life. Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily

Population: Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visits 2-6

Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visits 2-6

The HADS will be administered to assess anxiety and depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visits 2, 4 and 6

It is a 36-item questionnaire designed to measure general health related quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visits 4 and 6 the end of each of the two treatment periods

This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.

Outcome measures

Outcome data not reported

Adverse Events

Extended Release Oxycodone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immediate Release Oxycodone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Kent, MD

University of Rochester

Phone: 585-273-2972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place