Status:
COMPLETED
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Lead Sponsor:
NEMA Research, Inc.
Collaborating Sponsors:
Medtronic - MITG
International Clinical Research Institute
Conditions:
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 co...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01517295
Start Date
February 1 2012
End Date
September 1 2012
Last Update
July 28 2016
Active Locations (2)
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1
NEMA Research Inc. (CRO)
Naples, Florida, United States, 34108
2
International Clinical Research Institute
Leawood, Kansas, United States, 66211