MedTrace Logo

Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

NCT01517295 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-07-28

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Hydrocodone

Dose: Standard prescribed dose Frequency: Once Duration: Once

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • International Clinical Research Institute

    collaborator OTHER

  • NEMA Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Srinivas Nalamachu, MD · International Clinical Research Institute

  • Joseph Pergolizzi, MD · NEMA Research, Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517295 on ClinicalTrials.gov