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Trial record 35 of 663 for:    OXYCODONE

Open-Label Trial Comparing Oxycodone Medications (OUTCOMES)

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ClinicalTrials.gov Identifier: NCT01162304
Recruitment Status : Terminated (unable to enroll subjects meeting Eligibility criteria)
First Posted : July 14, 2010
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Joel Kent, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Drug: Extended Release Oxycodone
Drug: Immediate Release Oxycodone
Enrollment 18
Recruitment Details 1-20-2010 to 11-21-2013 at the medical center.
Pre-assignment Details 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.
Arm/Group Title ER Oxycodone vs IR Oxycodone
Hide Arm/Group Description

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

Period Title: Overall Study
Started 18
Completed 7
Not Completed 11
Reason Not Completed
Beck scale to high             11
Arm/Group Title ER Oxycodone vs IR Oxycodone
Hide Arm/Group Description

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 Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  88.9%
>=65 years
2
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
11
  61.1%
Male
7
  38.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
  61.1%
Unknown or Not Reported
7
  38.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  11.1%
White
9
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
7
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Numerical Pain Rating Scale (NRS)
Hide Description 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.
Time Frame Daily
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description:

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Brief Pain Inventory
Hide Description Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
Time Frame Visits 2-6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description:

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Hospital Anxiety and Depression Scale
Hide Description The HADS will be administered to assess anxiety and depression.
Time Frame Visits 2-6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description:

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Short Form Health Survey (SF-36)
Hide Description It is a 36-item questionnaire designed to measure general health related quality of life.
Time Frame Visits 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description:

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Patient Global Impression of Change
Hide Description 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.
Time Frame Visits 4 and 6 the end of each of the two treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description:

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended Release Oxycodone Immediate Release Oxycodone
Hide Arm/Group Description

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

All-Cause Mortality
Extended Release Oxycodone Immediate Release Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Extended Release Oxycodone Immediate Release Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extended Release Oxycodone Immediate Release Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joel Kent, MD
Organization: University of Rochester
Phone: 585-273-2972
EMail: joel_kent@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Joel Kent, University of Rochester
ClinicalTrials.gov Identifier: NCT01162304     History of Changes
Other Study ID Numbers: 29813
First Submitted: April 27, 2010
First Posted: July 14, 2010
Results First Submitted: March 26, 2015
Results First Posted: July 17, 2015
Last Update Posted: July 17, 2015