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Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

NCT00410943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2010-04-27

No results posted yet for this study

Summary

The purpose of this study was to characterize a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release) following administration of approximately equivalent total daily doses and demonstrate a significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for breakthrough pain medication use or alternatively, diary-based analgesic scores

Conditions

Interventions

DRUG

OROS Hydromorphone HCI SR (slow release)

Sponsors & Collaborators

  • Alza Corporation, DE, USA

    lead INDUSTRY

Principal Investigators

  • Alza Corporation Clinical Trial · ALZA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1999-06-30

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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 NCT00410943 on ClinicalTrials.gov