A randomised controlled trial in the palliative setting regarding off-label medication: investigating the efficiency of amitriptyline versus pregabalin from a societal perspective

A randomised controlled trial in the palliative setting regarding off-label medication: investigating the efficiency of amitriptyline versus pregabalin from a societal perspective - Amitriptyline or Pregabalin to treat neuropathic pain in incurable cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31425

Enrollment

130

Registered

2008-07-31

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathische pijn neuropathic pain

Interventions

When a patient agrees to take part in the study and has given informed consent, he will be allocated randomly to one of the two treatment groups. Each drug will be dosed in a step up titration proce

- major side-effects (meaning that the patient wants to stop the drug as a result of the side-effects): stop drug that causes side-effects and start drug of other arm in step up procedure as describ

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Curable cancer jonger dan 18 jaar Already using tricyclic antidepressive agents or anti-epileptic drugs Pregnant women

Design outcomes

Primary

Measure	Time frame
Mean current pain intensity self-rated by the patients with a 11-scale NRS ranged from no pain at all to the worst pain ever experienced, measured one time a day with the help of a pain diary. NRS ratings have been shown to be valid and reliable for measuring pain intensity.	—

Secondary

Measure	Time frame
- Costs (of medication and health care consumption) - Sort of pain and intensity (McGill Pain Questionnaire) - Mean number of episodes with breakthrough pain or pain attacks (pain diary) - Number of patients for whom the drug of first choice is not effective enough and therefere are given a prescription of the drug of the other arm (add-on) - Number of patients that stop to take the drug of first choice as a consequence of side-effects (switching, ADR) - Side-effects (EORTC QLQC30 - Number of different drugs prescribed for pain relief (using prescribed daily dose methodology, ATC/PDD) - Patient Global Impression of Change (PGIc) - Clinical Global Impression of Change (CGIC) - Presence of depression (BDI-PC) - Quality of Life (EORTC QLQC30; EQ-5D) - Costs (of all medications, consultations, home care, hospital care)	—

Measure

Time frame

- Costs (of medication and health care consumption) - Sort of pain and intensity (McGill Pain Questionnaire) - Mean number of episodes with breakthrough pain or pain attacks (pain diary) - Number of patients for whom the drug of first choice is not effective enough and therefere are given a prescription of the drug of the other arm (add-on) - Number of patients that stop to take the drug of first choice as a consequence of side-effects (switching, ADR) - Side-effects (EORTC QLQC30 - Number of different drugs prescribed for pain relief (using prescribed daily dose methodology, ATC/PDD) - Patient Global Impression of Change (PGIc) - Clinical Global Impression of Change (CGIC) - Presence of depression (BDI-PC) - Quality of Life (EORTC QLQC30; EQ-5D) - Costs (of all medications, consultations, home care, hospital care)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)