Who is sponsoring NCT00410878?

NCT00410878 is sponsored by Alza Corporation, DE, USA.

What condition does NCT00410878 study?

NCT00410878 studies Pain, Analgesics, Opioid.

What drugs are being tested in NCT00410878?

Interventions: OROS Hydromorphone HCI (slow release).

What is the status of NCT00410878?

NCT00410878 is currently COMPLETED.

Last reviewed 2017-02-15 · How we verify

A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets (Hydromorphone HCI) in Patients With Chronic Pain

NCT00410878 Phase 1 COMPLETED

The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids were converted to OROS hydromorphone slow release and titrated (slowly increased or decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10 days and had blood samples drawn over 24 hours on the last day of study.

Details

Lead sponsor	Alza Corporation, DE, USA
Phase	Phase 1
Status	COMPLETED
Enrolment	22
Completion	1999-08

Conditions

Pain
Analgesics, Opioid

Interventions

OROS Hydromorphone HCI (slow release)

Primary outcomes

The pharmacokinetic (absorption, distribution, excretion) profile of OROS hydromorphone. The time required for absorption and distribution in the body.