Clinical trial · Interventional
An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain
NCT01205126CI-TRIAL-00013638completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydromorphone HCl | Drug | — | UNRESOLVED |
| Oxycodone HCl CR | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OROS Hydromorphone hydrochloride (HCl)
- description
- OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose.
- interventionNames
- Drug: Hydromorphone HCl
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Oxycodone HCl Controlled release (CR)
- description
- Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.
- interventionNames
- Drug: Oxycodone HCl CR
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Participants receiving strong oral or transdermal (through the skin) opioid analgesics with inadequate control of moderate to severe (very serious, life threatening) cancer pain or who presented with cancer pain and will be eligible to move to Step 3 of the WHO analgesic ladder when receiving weak opioids * Participants who require or are expected to require between 40 mg and 184 mg of oral morphine or morphine equivalents every 24 hours for the chronic management of cancer pain * Participants who are reasonably expected to achieve a stable dose of opioid study medication during the study * Participants who are not expected to start a course of chemotherapy, radiotherapy, targeted cancer therapy, hormone therapy or diphosphates therapy after enrolment into the study. If participants are receiving long-term treatment including hormone therapy, target cancer therapy and diphosphate, the treatment should be kept stable as much as possible from 2 weeks before randomization and up to the completion of the study, encompassing the titration and maintenance phases * Female participants who are premenarchal, postmenopausal, or surgically sterile, abstinent or if sexually active, they must use a medically acceptable method of contraception and must be willing to continue to use the same method of contraception throughout the study Exclusion Criteria: * Participants with neuropathic pain or pain of unknown origin, or acute pain - Participants having pain only on movements * Participants requiring other opioid analgesics (apart from morphine hydrochloride (HCl), in immediate release formulation, allowed as rescue medication for breakthrough pain) * Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse * Women of childbearing potential who were pregnant or lactating, seeking pregnancy or failing to use an adequate contraceptive method
References
Publications (0)
Data not yet available
No reference posted for this study.