Safety and Tolerability of Long-Term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain - Full Text View

Sponsored by:	Alza Corporation, DE, USA
Information provided by:	Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:	NCT00410787

Purpose

The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the secondary purpose was to characterize the effects of pain on the patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow release) taken by patients with chronic cancer pain.

Condition	Intervention	Phase
Pain Analgesics, Opioid	Drug: OROS hydromorphone HCI (slow release)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:

Study results indicated that long-term treatment with OROS hydromorphone can be useful in the management of persistent, moderate-to-severe chronic pain in patients with cancer

Estimated Enrollment:	170
Study Completion Date:	April 2002

Detailed Description:

Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR (slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent to the opioid dose on which they had achieved dose-stable pain control in the SR (slow release) phase of Study DO-118. Patients returned to their study clinic once a month for 1 year. Dosage adjustments to study medications and breakthrough pain medication were permitted.

OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses administered orally every 24 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have chronic cancer pain, and who have successfully completed the OROS hydromorphone SR (slow release) study, DO-118
Patients must have been in dose-stable pain control in the last two days of the slow release phase of the study
Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours for the management of chronic cancer pain

Exclusion Criteria:

Pain which is not considered to be potentially responsive to opioids
Gastrointestinal disease of sufficient severity to be likely to interfere with oral analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within the 5 days prior to the start of the trial, severe gut narrowing that may affect the absorption or transit of orally administered drugs, particularly the insoluble OROS outer coating
Any patient in whom the risks of treatment with hydromorphone outweigh the potential benefits. Such risk categories include: raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders and Addison's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410787

Sponsors and Collaborators

Alza Corporation, DE, USA

Investigators

Study Director:

Alza Corporation Clinical Trial

Alza Corporation, DE, USA

More Information

No publications provided

Study ID Numbers:	CR013264
Study First Received:	December 12, 2006
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00410787 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:

Chronic cancer pain
long-term repeated dosing
OROS hydromorphone HCI (slow release)

Study placed in the following topic categories:

Hydromorphone
Central Nervous System Depressants
Narcotics
Pain

Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Hydromorphone
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009