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Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer (Off-label)

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ClinicalTrials.gov Identifier: NCT00740571
Recruitment Status : Unknown
Verified February 2009 by Radboud University.
Recruitment status was:  Recruiting
First Posted : August 25, 2008
Last Update Posted : February 5, 2009
Sponsor:
Collaborators:
Erasmus Medical Center
University of Amsterdam
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 25, 2008
Last Update Posted Date February 5, 2009
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
VAS score [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
EQ-5D, McGill, EORTC-C30, HADS [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer
Official Title  ICMJE A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective
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 cancer patients, pregabalin has been registered for neuropathic non-cancer pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label medication is not allowed anymore unless a standard or protocol exists. No clinical trials for this patient group have been published before.

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Neuralgia
Intervention  ICMJE
  • Drug: amitriptyline
    strategy in which the patient starts with amitriptyline, during 8 weeks
    Other Name: tryptizol
  • Drug: pregabalin
    Strategy in which patient starts with pregabalin
    Other Name: lyrica
Study Arms  ICMJE
  • Active Comparator: 1
    Strategy in which patient starts with amitriptyline
    Intervention: Drug: amitriptyline
  • Active Comparator: 2
    Strategy in which patient starts with pregabalin
    Intervention: Drug: pregabalin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740571
Other Study ID Numbers  ICMJE 80-82310-98-8612
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K.C.P. Vissers MD, PhD, FIPP, Radboud University Nijmegen Medical Centre
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Erasmus Medical Center
  • University of Amsterdam
Investigators  ICMJE
Study Director: Kris Vissers, MD PhD FIPP Radboud University
PRS Account Radboud University
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP