Clinical trial · Interventional
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
NCT02578459CI-TRIAL-00037120withdrawnN/AClinicalTrials.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): The study was never initiated by sponsor. Patients where never recruited.
Summary
Brief summary (as posted)
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic 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 Pain | — | UNRESOLVED | — |
| Pain Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Medical Management | Other | — | UNRESOLVED |
| Intrathecal Drug Delivery System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intrathecal Drug Delivery (ITDD)
- description
- These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
- interventionNames
- Device: Intrathecal Drug Delivery System
- type
- ACTIVE_COMPARATOR
- label
- Conventional Medical Management (CMM)
- description
- These subjects will be treated with conventional medical management to treat their pain.
- interventionNames
- Other: Conventional Medical Management
Primary outcomes (1)
- measure
- Visual Analog Scale Pain Scores
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient has Stage IV pancreatic cancer. 2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study. 3. Patient agrees not to obtain pain medications from other physicians during the study. 4. Patient is at least 22 years of age. 5. Investigator considers the patient to be able and willing to fulfill all study requirements. 6. Patient is able to understand the study and provide written informed consent to participate in the study. Exclusion Criteria: 1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group). 2. Patient is enrolled in another clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.