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Trial record 8 of 145 for:    Hydrocodone

Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Group 1   Group 2
STARTED   16   14 
COMPLETED   15   14 
NOT COMPLETED   1   0 
Physician Decision                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.63  (8.937)   54.28  (8.279)   48.60  (10.062) 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   5   4   9 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   16   13   29 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: 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   1   1   2 
White   15   13   28 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 


  Outcome Measures

1.  Primary:   Peak Plasma Concentration of Hydromorphone   [ Time Frame: Up to 6 hours ]

2.  Secondary:   Correlation of Plasma PK of Hydrocodone   [ Time Frame: 1 Month ]

3.  Secondary:   Peak Urine Concentration of Hydromorphone   [ Time Frame: Up to 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: nalamachu@yahoo.com


Publications:

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