Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
CompletedPhase 4NCT01517295
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP
- Conditions
- Interventions
- Drug: Hydrocodone
- Sponsor
- NEMA Research, Inc.
- Collaborators
- Medtronic - MITG; International Clinical Research Institute
- Start date
- 2012-02
- Primary completion
- 2012-05
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01517295