Who is sponsoring NCT00411034?

NCT00411034 is sponsored by Alza Corporation, DE, USA.

What condition does NCT00411034 study?

NCT00411034 studies Analgesics, Opioid, Pain.

What drugs are being tested in NCT00411034?

Interventions: OROS Hydromorphone HCI.

What is the status of NCT00411034?

NCT00411034 is currently COMPLETED.

Last reviewed 2010-04-26 · How we verify

A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain

NCT00411034 Phase 3 COMPLETED

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated.

Details

Lead sponsor	Alza Corporation, DE, USA
Phase	Phase 3
Status	COMPLETED
Enrolment	463
Completion	1999-09

Conditions

Analgesics, Opioid
Pain

Interventions

OROS Hydromorphone HCI

Primary outcomes

No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.