NCT00410748

CompletedPhase 3

Safety and Tolerability of Long-Term Administration of Hydro...

Alza Corporation, DE, USA Source

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Other study identifiers

Sponsor study identifier

CR011623

Study Type

interventional

Actual enrollment (reported)

388

Locations

0 countries

Sites

N/A

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

June 2000

Actual (reported)

Brief Summary

The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain.

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): 388 participants
Study completion date: June 2000
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
June 2000
Actual (reported)
First Submitted
December 12, 2006
Actual (reported)
First Posted
December 13, 2006
Actual (reported)

Last Updated: April 27, 2010
Status Verified: April 2010
Last Update Submitted: April 26, 2010

Conditions

Analgesics, Opioid Pain

Keywords

Chronic cancer painchronic pain

Outcome Measures

Primary Outcomes (1)

Effectiveness of OROS hydromorphone was maintained throughout the study. OROS hydromorphone provided moderate pain relief in patients with chronic cancer/chronic non-malignant pain.

Secondary Outcomes (1)

Long term administration of OROS hydromorphone was safe and well tolerated.

Interventions

OROS hydromorphone HCI CRDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients who have chronic cancer or chronic non-malignant pain, including pain associated with AIDS, who have successfully completed a OROS hydromorphone HCI (controlled release) short-term study (i.e. Study DO-104, DO-105, or DO-119)
Patients who require at least 8 mg of hydromorphone HCI every 24 hours for the management of chronic cancer or chronic non-malignant pain

Sponsors & Collaborators

Alza Corporation, DE, USA
Industrylead

Related Publications (1)

Wallace M, Moulin DE, Rauck RL, Khanna S, Tudor IC, Skowronski R, Thipphawong J. Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain. J Opioid Manag. 2009 Mar-Apr;5(2):97-105. doi: 10.5055/jom.2009.0011.
PMID: 19507806DERIVED

MeSH Terms

Conditions

PainChronic Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Alza Corporation Clinical Trial
ALZA
STUDY DIRECTOR

Enrollment

388 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
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

June 2000

Actual (reported)

Last Updated

Completed

NCT00410878

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

Phase 1Completed

NCT00410644

A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

Phase 3Completed

NCT00261495

A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

Phase 3Completed

NCT01205126

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

Phase 3Completed

NCT00141362

Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.

Phase 3Completed

NCT00412100

Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Phase 3Completed

Patients whose opioid requirements have been stable as demonstrated in a OROS hydromorphone HCI (controlled release) short-term study

You may not qualify if:

Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
Patients who are pregnant or breast-feeding
Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
Patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
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
Patients who are known active drug abusers or alcoholics

Contact the study team to confirm eligibility.

April 27, 2010

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.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00410748
Data provider: ClinicalTrials.gov
Source updated: 2010-04-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:02 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

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record