Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

June 17, 2016 updated by: NEMA Research, Inc.

Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Naples, Florida, United States, 34108
        • NEMA Research Inc. (CRO)
    • Kansas
      • Leawood, Kansas, United States, 66211
        • International Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Hydrocodone
Dose: Standard prescribed dose Frequency: Once Duration: Once
Other Names:
  • Vicodin
  • Hydrocodone/APAP
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.
Drug: Hydrocodone
Dose: Standard prescribed dose Frequency: Once Duration: Once
Other Names:
  • Vicodin
  • Hydrocodone/APAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Plasma PK of Hydrocodone
Time Frame: 1 Month
Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.
1 Month
Peak Urine Concentration of Hydromorphone
Time Frame: Up to 4 hours
Analyze the urine concentration of hydromorphone
Up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NEMA Research, Inc.

Collaborators

Medtronic - MITG
International Clinical Research Institute

Investigators

  • Study Director: Joseph Pergolizzi, MD, NEMA Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEMA-HydrocodonePK-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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