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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
18 Years
N/A
Open (Enrolling)
Both
Cancer, Neuralgia

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Trial Information

A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

VAS score

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Kris Vissers, MD PhD FIPP

Investigator Role:

Study Director

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

80-82310-98-8612

NCT ID:

NCT00740571

Start Date:

September 2008

Completion Date:

December 2010

Related Keywords:

  • Cancer
  • Neuralgia
  • neuralgia
  • off-label
  • cancer
  • Neuralgia

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