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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
| International Clinical Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone | Drug | Dose: Standard prescribed dose Frequency: Once Duration: Once |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Plasma PK of Hydrocodone | Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses. | 1 Month |
| Peak Urine Concentration of Hydromorphone | Analyze the urine concentration of hydromorphone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Nalamachu, MD | International Clinical Research Institute | Principal Investigator |
| Joseph Pergolizzi, MD | NEMA Research, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEMA Research Inc. (CRO) | Naples | Florida | 34108 | United States | ||
| International Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11499035 | Background | 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. | |
| 11936695 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/mL | Up to 6 hours |
|
From time of first dose of Hydrocodone to Completion of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srinivas Nalamachu | International Clinical Research Institute | 913.317.5300 | nalamachu@yahoo.com |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| C083640 | acetaminophen, hydrocodone drug combination |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Up to 4 hours |
| Leawood |
| Kansas |
| 66211 |
| United States |
| 12535841 | 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. |
| 14998425 | 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. |
| 37301 | 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. |
| 7693389 | 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. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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
|
|
| Secondary | Correlation of Plasma PK of Hydrocodone | Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses. | Analysis could not be performed because plasma levels analyzed were too low for the assay chosen. | Posted | 1 Month |
|
|
| Secondary | Peak Urine Concentration of Hydromorphone | Analyze the urine concentration of hydromorphone | Posted | Mean | Standard Deviation | ng/mL | Up to 4 hours |
|
|
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 0 | 14 | 0 | 14 |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Hour 4 |
|