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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.

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 25, 2012
Results First Submitted Date  ICMJE May 4, 2016
Results First Posted Date  ICMJE July 28, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
Peak Plasma Concentration of Hydromorphone [ Time Frame: Up to 6 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
Peak Plasma Concentration of Hydromorphone [ Time Frame: Up to 6 hours ]
Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame.
Change History Complete list of historical versions of study NCT01517295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
  • Correlation of Plasma PK of Hydrocodone [ Time Frame: 1 Month ]
    Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.
  • Peak Urine Concentration of Hydromorphone [ Time Frame: Up to 4 hours ]
    Analyze the urine concentration of hydromorphone
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Official Title  ICMJE Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP
Brief Summary Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
Detailed Description

Hydrocodone combinations are the most commonly prescribed pain medications in the United States. All the current available Hydrocodone formulations are short acting and have Acetaminophen/Ibuprofen in them. Chronic pain patients who take pain medications for extended time are overloaded with Acetaminophen and there is a very serious concern about liver failure from excessive concurrent alcohol use. Also all the current hydrocodone combinations available in the U.S. are short acting and provide pain relief for 3-6 hrs.

Hydromorphone is a metabolite of Hydrocodone and plays a significant role in providing pain relief in these patients. Although there are no long acting or extended release hydrocodone formulations that are FDA approve at this time, there is once a day extended release Hydromorphone (ER) approved by FDA and is currently marketed under the name Exalgo ®. PK study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency with hydromorphone ER, so that clinicians can use a simple conversion formula to switch to hydromorphone ER.

Although medical professionals use the Opiate conversion formula on a regular basis for Opioid rotation, there are no published studies showing the pharmacokinetic data in patients taking hydrocodone for chronic pain.

Our goal is to use this PK data to guide clinicians with this data in using extended release hydromorphone for chronic pain management to provide predictable pain relief and minimize the acetaminophen usage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Chronic Pain
Intervention  ICMJE Drug: Hydrocodone
Dose: Standard prescribed dose Frequency: Once Duration: Once
Other Names:
  • Hydrocodone/APAP
  • Vicodin
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Hydrocodone
  • Experimental: 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.
    Intervention: Drug: Hydrocodone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Man or woman aged 18-75
  • Documented clinical diagnosis of chronic pain.
  • Have been taking hydrocodone/APAP for their chronic non-cancer pain.
  • Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
  • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

  • Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
  • Health concerns that the study physician feels may confound study results.
  • Individuals who are cognitively impaired or who are not able to give informed consent.
  • Previous participation in a clinical research trial within 30 days prior to randomization.
  • The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01517295
Other Study ID Numbers  ICMJE NEMA-HydrocodonePK-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NEMA Research, Inc.
Study Sponsor  ICMJE NEMA Research, Inc.
Collaborators  ICMJE
  • Medtronic - MITG
  • International Clinical Research Institute
Investigators  ICMJE
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute
Study Director: Joseph Pergolizzi, MD NEMA Research, Inc.
PRS Account NEMA Research, Inc.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP