drugset / Trial / NCT03747562
Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.
Phase 3
Withdrawn
University Hospital, Ghent
Anglia Ruskin University · collabGeneral Hospital Groeninge · collabKU Leuven Campus Kulak Kortrijk · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
A multi-centre, double-blind, randomized-controlled trial to study the efficacy and safety of gabapentin to reduce the need for strong opioid use in the treatment of radiation-induced pain in head and neck cancer (HNCA) patients undergoing a curative 7-week radio(chemo)therapy course with curative intent. The aim of this study is to establish if addition of gabapentin is more effective in reducing the need to start (or dosage-increase) a strong opioid for HNCA pain than a matching placebo additional to standard pain management (WHO-ladder step 2 and 3).
Timeline
- Start
- 2019-03-01
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 100 mg | Oral |