NCT00410878

CompletedPhase 1

A Repeated Dose Study of the Metabolism and Action Evaluatio...

Alza Corporation, DE, USA Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CR011620

Study Type

interventional

Actual enrollment (reported)

22

Locations

0 countries

Sites

N/A

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

August 1999

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 22 participants
Study completion date: August 1999
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Completion
August 1999
Actual (reported)
First Submitted
December 12, 2006
Actual (reported)
First Posted
December 13, 2006
Actual (reported)

Last Updated: February 17, 2017
Status Verified: April 2010
Last Update Submitted: February 15, 2017

Conditions

Analgesics, Opioid Pain

Keywords

OpioidsChronic cancer painAnalgesic

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Relationships between pharmacokinetic (absorption, distribution, excretion) and pharmacodynamic (drug action on body systems) responses. Patients rated their pain intensity prior to each time blood was draw.

Interventions

OROS Hydromorphone HCI (slow release)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who had chronic nonmalignant or chronic cancer pain and were currently receiving strong oral or transdermal opioid analgesics (drug that relieves pain) on a daily basis or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic (drug that relieves pain) ladder

Sponsors & Collaborators

Alza Corporation, DE, USA
Industrylead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Alza Corporation Clinical Trial
ALZA
STUDY DIRECTOR

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Completion

August 1999

Actual (reported)

Last Updated

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Phase 1Completed

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Phase 1Completed

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Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions

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Phase 1Withdrawn

Patients who required the opioid equivalent of at least 32 mg but no more than 300 mg of oral morphine sulfate or opioid equivalent (exclusive of breakthrough pain medication) every 24 hours for the management of chronic nonmalignant or cancer pain

Patients who were expected to have reasonably stable opioid requirements for the duration of the study

You may not qualify if:

Patients intolerant of or hypersensitive to hydromorphone (or other opioid drugs)
Patients who were pregnant or breast-feeding.Patients with any dysphagia or unable to swallow tablets, acute abdominal conditions that may be obscured by opioids or gastrointestinal disorders, including pre-existing severe GI narrowing, that may affect the absorption or transit of orally administered drugs
Patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition, and clinically significant impaired hematological function
Patients that may be at risk for serious decreases in blood pressure following administration of an opioid analgesic (pain relief)

Contact the study team to confirm eligibility.

February 17, 2017

Record last verified: 2010-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00410878
Data provider: ClinicalTrials.gov
Source updated: 2017-02-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:04 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record