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PK of Hydromorphone in Chronic Pain Patients on Hydrocodone
NCT01517295Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2012
- Primary completion
- May 2012
- Countries
- 1
- Sponsor
- NEMA Research
- Modality
- Small Molecules
- Drugs
- hydrocodone
- Conditions
- chronic pain
01
Overview
Phase 4, randomised, open-label trial of hydrocodone in chronic pain (2 arms), sponsored by NEMA Research. Primary endpoint: Peak Plasma Concentration of Hydromorphone at 6 hours. Started Feb 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Group 1
Blood draws at 0, 1, 3, 5 hours
Group 2
Blood draws at 0, 2, 4, 6 hours
03
Who it enrols
Adult patients (18-75) with documented chronic non-cancer pain who have been taking hydrocodone/APAP (min 15mg hydrocodone daily) for at least 30 days. Excludes those with substance abuse or taking interfering medications.
04
Endpoints
Primary
Peak Plasma Concentration of Hydromorphone
Secondary
Correlation of Plasma PK of Hydrocodone
Peak Urine Concentration of Hydromorphone
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