Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

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

The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.

Condition Intervention Phase
Low Back Pain
Drug: OROS hydromorphone HCI SR (slow release)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain

Resource links provided by NLM:

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

Primary Outcome Measures:
  • The daily pain relief rating obtained during the study.(six months)

Secondary Outcome Measures:
  • Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.

Enrollment: 207
Study Completion Date: June 2001
Detailed Description:

This open label, extension study characterized the safety, effectiveness, and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term Study DO-127 with OROS hydromorphone slow release. Up to 150 patients were to be enrolled and evaluated. Patients were enrolled in this study immediately following Study DO-127. Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study. The patient's initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127. Patients returned monthly for evaluations during this extension interval. Adjustments to dose were performed as needed, at the Investigator's discretion. The duration of this study was six months. Safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of OROS hydromorphone (dose will be at Investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study


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

Inclusion Criteria:

  • Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
  • Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
  • Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release

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 significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
  • Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
  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 identifier: NCT00411268

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

No publications provided Identifier: NCT00411268     History of Changes
Other Study ID Numbers: CR013258
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 low back pain
OROS hydromorphone slow release tablet
Quality of Life

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 01, 2015