Clinical trial · Interventional
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.
A Randomized, Double-Blind, Controlled Trial of Hydromorphone (Immediate and Sustained- Release) vs Morphine (Immediate and Sustained-release) in Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release \[IR\] and sustained-release \[SR\] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesics, Opioid | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OROS hydromorphone HCL ; Morphine sulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary efficacy : Patient's assessment of "worst pain in the past 24 hours" Brief Pain Inventory (BPI) questions, scored daily in the patient's diary.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cancer pain who are currently receiving strong oral or transdermal opioid analgesics or in whom strong opioid analgesics are appropriate * Patients who requires or are expected to require between 60 and 540 mg of oral morphine or morphine equivalents every 24 hours for the chronic management of cancer pain * Patients who have pain suitable for treatment with a once-daily formulation * Patients with concomitant chemotherapy or radiotherapy. Exclusion Criteria: * Patient with gastrointestinal (GI) disease of sufficient severity to interfere with orally administered analgesia (eg dysphagia, vomiting, constipation, bowel obstruction, severe gut narrowing) were not permitted to enroll * Patient where the risks of treatment with morphine or hydromorphone outweighed the potential benefits such as raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic or renal impairment, convulsive disorders, and Addison's disease * Debilitated patients were excluded.
References
Publications (0)
Data not yet available