Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management
Conditions
Interventions
All participants receive oral administration of Ivabradine. The dosage of ivabradine will range from 2.5 mg to 7.5 mg twice daily. The starting dose is 2.5mg twice daily for all participants, if toler
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to give voluntary written informed consent to participate 2. Aged 18 years and above 3. Have peripheral neuropathic pain from diabetes, herpes zoster infection, or trauma to peripheral nerve trunks/plexus (from surgery or physical injury) and DN4 score = 4 4. Have pain for 6 months or more 5. Have pain rated > 4 on a numerical rating scale (NRS) (0= No pain; 10= pain as bad as you can imagine) on at least one Pain sub-item from Brief Pain Inventory 6. Be registered with a GP 7. Have the following findings on standard ECG at screening: 7.1. Normal sinus rhythm (measured for 1 minute on lead II) 7.2. PR interval = 210 ms 7.3. QTcB = 430 ms for men and QTcB = 450 ms for women 7.4. QRS duration = 120 ms 7.5. Heart rate = 60 beats per minute
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to ivabradine or have hypersensitivity to any of the formulation ingredients 2. Current treatment with ivabradine 3. Use of drugs with potential serious interactions with Ivabradine – as indicated by the latest version of British National Formulary at the time of screening 4. Currently receiving or have received prior to the screening (Visit 1) any of Prohibited Concomitant Medications 5. Have pain rated = 10 a numerical rating scale (NRS) (0= No pain; 10= pain as bad as you can imagine) on ALL pain sub-items from Brief Pain Inventory 6. Scheduled for clinical treatment (e.g. drugs, psychological therapy, surgical or interventional treatment) for any chronic pain or other health condition for the anticipated duration of the study 7. New York Heart Association heart failure class II or higher, or hospitalization for heart failure within a year 8. Myocardial infarct, coronary revascularization, stroke or transient ischemic attack within 6 months of the screening visit 9. Transplanted heart, implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy 10. Scheduled for coronary revascularization; or likely to require cardiac surgery for valvular disease 11. Known congenital long QT, permanent atrial fibrillation or flutter, sick sinus syndrome, sinoatrial block, second and complete atrio-ventricular block 12. Severe or uncontrolled hypertension with systolic BP > 180mmHg or diastolic BP > 110 mmHg after sitting for at least 5 minutes 13. Sitting systolic BP < 85mmHg or symptomatic hypotension 14. Active uncontrolled psychiatric illness (e.g. severe depression (risk of self-harm), schizophrenia, substance misuse or dependence) 15. Known severe renal disease, or moderate or severe liver disease 16. Known to be HIV, Hepatitis B or C seropositive (Level 3 containment laboratory procedures are not available for the handling of infectious specimens) 17. Any illness or condition that in the opinion of the PI or delegated investigators, precludes safe participation in the Study or interferes with Study procedures. 18. Currently participating in any interventional Study, have participated in an interventional Study within 12 weeks of screening or are currently enrolled in a non-interventional Study, which participating in this Study would impact upon 19. Unwilling for the GP to be notified or to provide information relevant to the participation of the clinical Study 20. Transaminases ALT and AST greater than three times the upper normal limit 21. Haemoglobin <11.0g/dL 22. Creatinine clearance (Cockcroft-Gault – section 21.4 of the protocol) < 50 ml/min/1.73m2 23. Females of childbearing potential who decline to use adequate contraceptive measures for the duration of the study 24. Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily Pain: Numerical ratings (0=no pain, 10= worst possible pain) scores, recorded daily, starting measured 2 weeks prior to dose initiation till follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures are obtained once per visit starting the day before the dose initiation: 1. Overall Pain (between visits) is measured using the Brief Pain Inventory-SF (BPI) questionnaire 2. Sleep is measured using the Insomnia Severity Index (ISI) questionnaire 3. Physical function is measured using the Pain Disability Index (PDI) questionnaire 4. Neuropathic pain sensations are measured using the Neuropathic Pain Symptom Inventory (NPSI) questionnaire 5. Mood is measured using the Depression, Anxiety and Positive Outlook Scale (DAPOS) questionnaire 6. Skin sensitivity is measured using the Sensory scores with punctate and brush stimuli | — |
Countries
England, United Kingdom
Contacts
Public ContactMichael Lee
Outcome results
None listed