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Trial record 8 of 146 for:    Hydrocodone

Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT01517295
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Collaborators:
Medtronic - MITG
International Clinical Research Institute
Information provided by (Responsible Party):
NEMA Research, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Chronic Pain
Intervention Drug: Hydrocodone
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 16 14
Completed 15 14
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
43.63  (8.937) 54.28  (8.279) 48.60  (10.062)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
11
  68.8%
10
  71.4%
21
  70.0%
Male
5
  31.3%
4
  28.6%
9
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Hispanic or Latino
0
   0.0%
1
   7.1%
1
   3.3%
Not Hispanic or Latino
16
 100.0%
13
  92.9%
29
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
1
   7.1%
2
   6.7%
White
15
  93.8%
13
  92.9%
28
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Peak Plasma Concentration of Hydromorphone
Hide Description 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.
Time Frame Up to 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
Hour 0 0  (0) 0  (0)
Hour 1 0  (0) NA [1]   (NA)
Hour 2 NA [1]   (NA) 0  (0)
Hour 3 0  (0) NA [1]   (NA)
Hour 4 NA [1]   (NA) 0  (0)
Hour 5 0  (0) NA [1]   (NA)
Hour 6 NA [1]   (NA) 0  (0)
[1]
No blood drawn at this time point
2.Secondary Outcome
Title Correlation of Plasma PK of Hydrocodone
Hide Description Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.
Time Frame 1 Month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Peak Urine Concentration of Hydromorphone
Hide Description Analyze the urine concentration of hydromorphone
Time Frame Up to 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
Hour 0 726.69  (1294.77) 211.36  (248.356)
Hour 3 815.63  (1396.38) NA [1]   (NA)
Hour 4 NA [1]   (NA) 205.57  (239.508)
[1]
No urine was taken at this time point.
Time Frame From time of first dose of Hydrocodone to Completion of study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

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

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

All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Srinivas Nalamachu
Organization: International Clinical Research Institute
Phone: 913.317.5300
Responsible Party: NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01517295     History of Changes
Other Study ID Numbers: NEMA-HydrocodonePK-001
First Submitted: January 4, 2012
First Posted: January 25, 2012
Results First Submitted: May 4, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016