Clinical trial · Interventional
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients
NCT00492388CI-TRIAL-00006032terminatedPhase 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): Business decision not to continue development
Summary
Brief summary (as posted)
To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| PMI-150 (intranasal ketamine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- PMI-150 (intranasal ketamine)
- interventionNames
- Drug: PMI-150 (intranasal ketamine)
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- pain intensity difference
- timeFrame
- 60 minutes
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * at least 18 years of age * Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain Exclusion Criteria: * under 18 years * non-cancer pain * allergy to ketamine
References
Publications (0)
Data not yet available
No reference posted for this study.