Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00410748
First received: December 12, 2006
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Pain
Analgesics, Opioid
Drug: OROS hydromorphone HCI CR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Long term administration of OROS hydromorphone was safe and well tolerated.

Enrollment: 388
Study Completion Date: June 2000
Detailed Description:

This was a Phase 3, multicenter, open-label, extension study to characterize the safety and tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of approximately 4 weeks duration. During this study, patients continued to receive the dose of OROS hydromorphone that they had been receiving in the short-term study, with dose adjustments as needed to control pain and adverse events. Patients were treated on an outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly evaluations of patients treated with OROS hydromorphone for chronic pain were performed to identify adverse events, construct a safety and tolerability profile, and assess efficacy. Dose adjustments were permitted to provide for disease progression, pain control, and adverse events. Quarterly physical examinations were performed to detect significant changes in the underlying condition of patients or changes that may have been associated with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8, 16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to control pain and adverse events.

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410748

Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

No publications provided by Alza Corporation, DE, USA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00410748     History of Changes
Other Study ID Numbers: CR011623
Study First Received: December 12, 2006
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:
Chronic cancer pain
chronic pain

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 26, 2014