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A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain

NCT00410878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Pain
  • Analgesics, Opioid

Interventions

DRUG

OROS Hydromorphone HCI (slow release)

Sponsors & Collaborators

  • Alza Corporation, DE, USA

    lead INDUSTRY

Principal Investigators

  • Alza Corporation Clinical Trial · ALZA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Completion
1999-08-31

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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 NCT00410878 on ClinicalTrials.gov