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Sponsored by: |
Alza Corporation, DE, USA |
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Information provided by: | Alza Corporation, DE, USA |
ClinicalTrials.gov Identifier: | NCT00411268 |
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 |
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Low Back Pain |
Drug: OROS hydromorphone HCI SR (slow release) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Completion Date: | June 2001 |
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:
Exclusion Criteria:
Study ID Numbers: | CR013258 |
Study First Received: | December 12, 2006 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00411268 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic low back pain OROS hydromorphone slow release tablet Quality of Life |
Hydromorphone Signs and Symptoms Central Nervous System Depressants Quality of Life Neurologic Manifestations Low Back Pain |
Narcotics Pain Peripheral Nervous System Agents Analgesics Back Pain Analgesics, Opioid |
Hydromorphone Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Low Back Pain Narcotics Pain Back Pain Pharmacologic Actions |
Signs and Symptoms Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |