Phase 4
Completed N=30
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Source: ClinicalTrials.gov NCT01517295 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Peak Plasma Concentration of Hydromorphone — 0; 0; 0; NA ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration of Hydromorphone |
0; 0; 0; NA; NA; 0 | — |
| SECONDARY Correlation of Plasma PK of Hydrocodone |
— | — |
| SECONDARY Peak Urine Concentration of Hydromorphone |
726.69; 211.36; 815.63; NA; NA; 205.57 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01517295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.