Status:
UNKNOWN
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
University of Amsterdam
Conditions:
Cancer
Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain in incurable ...
Eligibility Criteria
Inclusion
- Age 18+
- 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
- Previous use of TAD or AED for neuropathic pain within 30 days prior to screening
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00740571
Start Date
September 1 2008
End Date
December 1 2010
Last Update
February 5 2009
Active Locations (2)
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1
VUMC
Amsterdam, North Holland, Netherlands, 1007MB
2
Erasmus MC
Rotterdam, South Holland, Netherlands, 3000CA