A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain
CompletedPhase 2NCT00398788
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of the study was to characterize the safety, effectiveness, and impact on quality of life (QOL) measures of OROS® hydromorphone HCL in patients with chronic low back pain.
Study details
- Official title
- An Open-Label, Repeated-Dose Trial to Characterize the Efficacy and Safety, and Impact on Quality of Life Measures of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
- Conditions
- Interventions
- Drug: OROS® hydromorphone HCL
- Dilaudid CR (controlled release)
- Dilaudid IR (immediate release) as rescue medicine
- Sponsor
- Alza Corporation, DE, USA
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient with chronic low back pain who were currently receiving strong oral or transdermal opioid analgesics on a daily basis, or patients suitable for advancement of therapy to step 3 of the World Health Organization (WHO) analgesic ladder were considered for enrollment in the study. Patients requiring \>8 and =96 mg of OROS® hydromorphone HCL every 24 hours were enrolled in the study. Exclusion Criteria: * Patients intolerant or hypersensitive to hydromorphone or other opioid agonists and patients with a known history of alcohol or drug abuse within the previous year were excluded from study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00398788