Trial Outcomes & Findings for Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients (NCT NCT01517295)
NCT ID: NCT01517295
Last Updated: 2016-07-28
Results Overview
Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Up to 6 hours
Results posted on
2016-07-28
Participant Flow
Participant milestones
| Measure |
Group 1
Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Group 2
Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1
Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Group 2
Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Group 2
n=14 Participants
Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.63 years
STANDARD_DEVIATION 8.937 • n=5 Participants
|
54.28 years
STANDARD_DEVIATION 8.279 • n=7 Participants
|
48.60 years
STANDARD_DEVIATION 10.062 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 hoursDetermine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.
Outcome measures
| Measure |
Group 1
n=16 Participants
Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Group 2
n=14 Participants
Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
|---|---|---|
|
Peak Plasma Concentration of Hydromorphone
Hour 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Peak Plasma Concentration of Hydromorphone
Hour 1
|
0 ng/mL
Standard Deviation 0
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
|
Peak Plasma Concentration of Hydromorphone
Hour 2
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
0 ng/mL
Standard Deviation 0
|
|
Peak Plasma Concentration of Hydromorphone
Hour 3
|
0 ng/mL
Standard Deviation 0
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
|
Peak Plasma Concentration of Hydromorphone
Hour 4
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
0 ng/mL
Standard Deviation 0
|
|
Peak Plasma Concentration of Hydromorphone
Hour 5
|
0 ng/mL
Standard Deviation 0
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
|
Peak Plasma Concentration of Hydromorphone
Hour 6
|
NA ng/mL
Standard Deviation NA
No blood drawn at this time point
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.
Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 hoursAnalyze the urine concentration of hydromorphone
Outcome measures
| Measure |
Group 1
n=16 Participants
Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
Group 2
n=14 Participants
Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
|
|---|---|---|
|
Peak Urine Concentration of Hydromorphone
Hour 0
|
726.69 ng/mL
Standard Deviation 1294.77
|
211.36 ng/mL
Standard Deviation 248.356
|
|
Peak Urine Concentration of Hydromorphone
Hour 3
|
815.63 ng/mL
Standard Deviation 1396.38
|
NA ng/mL
Standard Deviation NA
No urine was taken at this time point.
|
|
Peak Urine Concentration of Hydromorphone
Hour 4
|
NA ng/mL
Standard Deviation NA
No urine was taken at this time point.
|
205.57 ng/mL
Standard Deviation 239.508
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
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
Srinivas Nalamachu
International Clinical Research Institute
Phone: 913.317.5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place