Clinical trial · Interventional
NP2 Enkephalin For Treatment of Intractable Cancer Pain
A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
NCT01291901CI-TRIAL-00015347completedPhase 2ClinicalTrials.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 examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.
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 |
|---|---|---|---|
| Intractable Pain | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NP2 | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active NP2
- description
- Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
- interventionNames
- Biological: NP2
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Pain Measured by the Numerical Rating Scale (NRS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Histologically confirmed malignant disease. * Intractable pain related to malignancy. * Females must be postmenopausal or practicing birth control. * Able to provide appropriate written consent. Main Exclusion Criteria: * Positive pregnancy test prior to receiving study treatment. * Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes). * Evidence of active Hepatitis B, Hepatitis C, or HIV infection. * Evidence of viral, bacterial, or fungal infection in the planned treatment area.
References
Publications (0)
Data not yet available
No reference posted for this study.