Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

Completed · Phase 4

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT01517295

Run by

NEMA Research, Inc.

People needed

30

Starts

2012-02-01

Expected to finish

2012-09-01

Last updated by the study team

2016-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• NEMA Research Inc. (CRO) — Naples, Florida, United States
• International Clinical Research Institute — Leawood, Kansas, United States

Full record on ClinicalTrials.gov

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