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

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Hydrocodone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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:
  • Hydrocodone/APAP
  • Vicodin

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:
  • Hydrocodone/APAP
  • Vicodin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Correlation of Plasma PK of Hydrocodone [ Time Frame: 1 Month ]
    Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.

  2. Peak Urine Concentration of Hydromorphone [ Time Frame: Up to 4 hours ]
    Analyze the urine concentration of hydromorphone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517295

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United States, Florida
NEMA Research Inc. (CRO)
Naples, Florida, United States, 34108
United States, Kansas
International Clinical Research Institute
Leawood, Kansas, United States, 66211
Sponsors and Collaborators
NEMA Research, Inc.
Medtronic - MITG
International Clinical Research Institute
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Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute
Study Director: Joseph Pergolizzi, MD NEMA Research, Inc.

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Responsible Party: NEMA Research, Inc. Identifier: NCT01517295     History of Changes
Other Study ID Numbers: NEMA-HydrocodonePK-001
First Posted: January 25, 2012    Key Record Dates
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016
Last Verified: June 2016
Keywords provided by NEMA Research, Inc.:
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Analgesics, Non-Narcotic