A randomised controlled trial in the palliative setting regarding off-label medication: investigating the efficiency of amitriptyline versus pregabalin from a societal perspective
Phase 3
Completed
- Conditions
- neuropathische pijnneuropathic pain
- Registration Number
- NL-OMON31425
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
All patients, belonging to the above mentioned target group, that have a rating of 4 or higher on a NRS
Recently diagnosed
18+
Exclusion Criteria
Curable cancer
jonger dan 18 jaar
Already using tricyclic antidepressive agents or anti-epileptic drugs
Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean current pain intensity self-rated by the patients with a 11-scale NRS<br /><br>ranged from no pain at all to the worst pain ever experienced, measured one<br /><br>time a day with the help of a pain diary. NRS ratings have been shown to be<br /><br>valid and reliable for measuring pain intensity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Costs (of medication and health care consumption)<br /><br>- Sort of pain and intensity (McGill Pain Questionnaire)<br /><br>- Mean number of episodes with breakthrough pain or pain attacks (pain diary)<br /><br>- Number of patients for whom the drug of first choice is not effective enough<br /><br>and therefere are given a prescription of the drug of the other arm (add-on)<br /><br>- Number of patients that stop to take the drug of first choice as a<br /><br>consequence of side-effects (switching, ADR)<br /><br>- Side-effects (EORTC QLQC30<br /><br>- Number of different drugs prescribed for pain relief (using prescribed daily<br /><br>dose methodology, ATC/PDD)<br /><br>- Patient Global Impression of Change (PGIc)<br /><br>- Clinical Global Impression of Change (CGIC)<br /><br>- Presence of depression (BDI-PC)<br /><br>- Quality of Life (EORTC QLQC30; EQ-5D)<br /><br>- Costs (of all medications, consultations, home care, hospital care)</p><br>