Clinical trial · Interventional
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
NCT00911261CI-TRIAL-00003152completedPhase 3ClinicalTrials.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 determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Pain | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxymorphone Extended Release | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: Oxymorphone Extended Release
Primary outcomes (1)
- measure
- Tolerability
- timeFrame
- Throughout the study
Secondary outcomes (8)
- measure
- Average daily pain intensity (Question 5 of BPI)
- timeFrame
- Week 1-4, Month 12
- measure
- Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire
- timeFrame
- Week 1-4, Month 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either: 1. have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or 2. have intolerable side effects to one or more components of their current opioid-containing analgesic regimen. * Currently receive a stable (at least 2 weeks duration) analgesic regimen * If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). * Understand written and spoken English * Have been informed of the nature of the study and provided written informed consent Additional Inclusion Criteria for Cancer Patients Only: * Have a life expectancy of at least 12 months Additional Inclusion Criteria for Neuropathic Patients Only: * Have a diagnosis of: * post-herpetic neuralgia (PHN) * diabetic neuropathy (DN) * complex regional pain syndrome (CRPS) * HIV neuropathy * idiopathic sensory neuropathy * traumatic peripheral neuropathy * central neuropathic pain condition (spinal cord injury, post-stroke pain), OR * other peripheral neuropathy (upon mutual agreement of the sponsor and investigator). Exclusion Criteria: * Have a positive pregnancy test (females only) * Have a history of or active asthma or emphysema * Have clinically significant hepatic impairment * Have a history of alcohol or substance abuse within the last 3 years * Have a history of opioid abuse within 6 months prior to study entry * Have a known allergy or significant reaction to opioids, including codeine * Have a known oxymorphone sensitivity or allergy * Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
References
Publications (0)
Data not yet available
No reference posted for this study.