Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NEMA Research, Inc.
• Collaborators: International Clinical Research Institute; Medtronic - MITG
• Treatments: Acetaminophen; Hydrocodone; Hydromorphone

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.