Clinical trial · Interventional
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain
NCT00126789CI-TRIAL-00007055terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Based on PK data, product did not meet requirement for further development.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Transdermal Matrix Patch ZR-02-01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZR-02-01
- description
- ZR-02-01 matrix transdermal fentanyl patch
- interventionNames
- Drug: Fentanyl Transdermal Matrix Patch ZR-02-01
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 12 weeks
- description
- To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
Secondary outcomes (2)
- measure
- Pain intensity
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is at least 18 and no older than 75 years of age at the time of screening * Patient has a diagnosis of cancer * Patient has moderate to severe pain that is related to cancer or its treatment and is expected to last indefinitely and is currently taking an around-the-clock opioid to treat his/her pain * Patient is already receiving opioid therapy, has demonstrated opioid tolerance * A responsible adult caregiver is available in the event of an emergency at home Exclusion Criteria: * Patient has uncontrolled or rapidly escalating pain as determined by the investigator * Patient has a history of substance abuse or has a substance abuse disorder
References
Publications (0)
Data not yet available
No reference posted for this study.