Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

NCT01517295 | Completed Phase 4 Results DMC

• 1 other identifier: NEMA-HydrocodonePK-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Pharmacokinetics; Hydromorphone; Hydrocodone; APAP

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration of Hydromorphone

  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 Outcomes (2)

• Correlation of Plasma PK of Hydrocodone

  1 Month

• Peak Urine Concentration of Hydromorphone

  Up to 4 hours

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

Hydrocodone DRUG

Dose: Standard prescribed dose Frequency: Once Duration: Once

Also known as: Hydrocodone/APAP, Vicodin

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEMA Research, Inc.: lead
• Medtronic - MITG: collaborator
• International Clinical Research Institute: collaborator

Study Sites (2)

NEMA Research Inc. (CRO)

Naples, Florida, 34108, United States

Location

International Clinical Research Institute

Leawood, Kansas, 66211, United States

Location

Related Publications (6)

• Wu Y. [Studies on the analysis of hydrocodone and its metabolite in human urine by GC/MS]. Yao Xue Xue Bao. 1997 Apr;32(4):305-9. Chinese.

  PMID: 11499035 BACKGROUND

• Chen YL, Hanson GD, Jiang X, Naidong W. Simultaneous determination of hydrocodone and hydromorphone in human plasma by liquid chromatography with tandem mass spectrometric detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Mar 25;769(1):55-64. doi: 10.1016/s1570-0232(01)00616-x.

  PMID: 11936695 BACKGROUND

• Menelaou A, Hutchinson MR, Quinn I, Christensen A, Somogyi AA. Quantification of the O- and N-demethylated metabolites of hydrocodone and oxycodone in human liver microsomes using liquid chromatography with ultraviolet absorbance detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Feb 25;785(1):81-8. doi: 10.1016/s1570-0232(02)00856-5.

  PMID: 12535841 BACKGROUND

• Hutchinson MR, Menelaou A, Foster DJ, Coller JK, Somogyi AA. CYP2D6 and CYP3A4 involvement in the primary oxidative metabolism of hydrocodone by human liver microsomes. Br J Clin Pharmacol. 2004 Mar;57(3):287-97. doi: 10.1046/j.1365-2125.2003.02002.x.

  PMID: 14998425 BACKGROUND

• Cone EJ, Darwin WD, Gorodetzky CW. Comparative metabolism of codeine in man, rat, dog, guinea-pig and rabbit: identification of four new metabolites. J Pharm Pharmacol. 1979 May;31(5):314-7. doi: 10.1111/j.2042-7158.1979.tb13507.x.

  PMID: 37301 BACKGROUND

• Otton SV, Schadel M, Cheung SW, Kaplan HL, Busto UE, Sellers EM. CYP2D6 phenotype determines the metabolic conversion of hydrocodone to hydromorphone. Clin Pharmacol Ther. 1993 Nov;54(5):463-72. doi: 10.1038/clpt.1993.177.

  PMID: 7693389 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Hydrocodone; acetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Srinivas Nalamachu
• Organization: International Clinical Research Institute

nalamachu@yahoo.com

913.317.5300

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Joseph Pergolizzi, MD

  NEMA Research, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 28, 2016
• Results First Posted: July 28, 2016

Record last verified: 2016-06

Locations

US (2)