Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
NCT ID: NCT00740571
Last Updated: 2009-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
130 participants
INTERVENTIONAL
2008-09-30
2010-12-31
Brief Summary
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Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.
Study design: An open label, randomised non-inferiority trial Study population: Incurable cancer patients with neuropathic pain Intervention: When a patient decides to take part in the study, he will be allocated randomly to one of the two study groups. A minimisation algorithm will be used, that balances for the cause of neuropathic pain (tumour related versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up procedure. Patients will be followed during 8 weeks.
Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill questionnaire, strategy success, costs per strategy, side effects, quality of life and concomitant analgesic drugs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are hardly any risks for the patients. The drugs in both arms already are usual care for the target population. If there is no or a too small effect, the drug of the other arm will be added, which strategy also is already usual care. All other medication, except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times during the study period. The patient had to fill in a pain diary daily (5 min), cost diary and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30 monthly (20 min).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Strategy in which patient starts with amitriptyline
amitriptyline
strategy in which the patient starts with amitriptyline, during 8 weeks
2
Strategy in which patient starts with pregabalin
pregabalin
Strategy in which patient starts with pregabalin
Interventions
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amitriptyline
strategy in which the patient starts with amitriptyline, during 8 weeks
pregabalin
Strategy in which patient starts with pregabalin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Incurable cancer
* Life expectancy three months or longer
* NRS ≥ 4
* Neuropathic pain
* Adequate renal function with cockroft ≥ 60 ml/min
* Signed informed consent
* Expected adequacy of follow up
Exclusion Criteria
* Unstable regime of analgetica for 1 week prior to screening
* Use of cannabis
* Radiotherapy aimed at the source of the neuropathic pain 2 weeks before screening
* Chemotherapy with known neurotoxic effect (taxanes, thalidomide, vinca alkaloids, cytarabine,fluoropyrimidines, oxaliplatin) 2 weeks before screening
* Unstable regime of corticosteroids for 1 week prior to screening
* Pregnancy
* Any condition preventing the intake or absorption of oral drugs
* Participation in any other studies involving investigational products within the 30 days prior to screening
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
University of Amsterdam
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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Kris Vissers, MD PhD FIPP
Role: STUDY_DIRECTOR
Radboud University Medical Center
Locations
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VUMC
Amsterdam, North Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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80-82310-98-8612
Identifier Type: -
Identifier Source: org_study_id
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