Clinical trial · Interventional
Open Label Assessment of Long-Term Safety and Utility
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer
NCT00904449CI-TRIAL-00003137completedPhase 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 monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxymorphone ER | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open Label
- interventionNames
- Drug: Oxymorphone ER
Primary outcomes (1)
- measure
- Assessment of AEs and clinical laboratory values
- timeFrame
- 22 months
Secondary outcomes (1)
- measure
- Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer
- timeFrame
- 22 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females aged \> 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics. * Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study. * Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible. Exclusion Criteria: * Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication. * Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication. * Known idiosyncratic reaction or hypersensitivity to oxymorphone. * Inability to take oral medication for 1 week. * Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.
References
Publications (0)
Data not yet available
No reference posted for this study.