Clinical trial · Interventional
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.
Summary
Brief summary (as posted)
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Visceral Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Pregabalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Conventional analgesic treatment + pregabalin.
- interventionNames
- Drug: Pregabalin
- type
- PLACEBO_COMPARATOR
- label
- Group II
- description
- Conventional analgesic treatment + placebo.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Pain intensity (Visual Analogue Scale; VAS Score)
- timeFrame
- From baseline to day 90.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Patients \> 18 years old recently diagnosed of pancreatic cancer (\<3 months). * 2\. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. * 3\. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures. Exclusion Criteria: * 1\. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator. * 2\. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) \< 60mL/min should be excluded. * 3\. Patients treated with anticonvulsants during the previous 4 months.
References
Publications (0)
Data not yet available