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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Erasmus Medical Center
VU University of Amsterdam
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00740571
First received: August 22, 2008
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention Phase
Cancer
Neuralgia
Drug: amitriptyline
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • VAS score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EQ-5D, McGill, EORTC-C30, HADS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Strategy in which patient starts with amitriptyline
Drug: amitriptyline
strategy in which the patient starts with amitriptyline, during 8 weeks
Other Name: tryptizol
Active Comparator: 2
Strategy in which patient starts with pregabalin
Drug: pregabalin
Strategy in which patient starts with pregabalin
Other Name: lyrica

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740571

Contacts
Contact: Yvonne Engels, PhD +31243616583 y.engels@anes.umcn.nl
Contact: Annelies Schalkwijk, MSc +31243666254 a.schalkwijk@anes.umcn.nl

Locations
Netherlands
VUMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1007MB
Contact: Roberto Perez, PhD    +31204440029    rsgm.perez@vumc.nl   
Principal Investigator: Roberto Perez, PhD         
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Contact: Carin vd Rijt, MD, PhD    +31104391906    c.vanderrijt@erasmusmc.nl   
Principal Investigator: Carin vd Rijt, MD, PhD         
Sponsors and Collaborators
Radboud University
Erasmus Medical Center
VU University of Amsterdam
Investigators
Study Director: Kris Vissers, MD PhD FIPP Radboud University
  More Information

No publications provided

Responsible Party: K.C.P. Vissers MD, PhD, FIPP, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00740571     History of Changes
Other Study ID Numbers: 80-82310-98-8612
Study First Received: August 22, 2008
Last Updated: February 4, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
neuralgia
off-label
cancer

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Amitriptyline
Amitriptyline, perphenazine drug combination
Pregabalin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 23, 2014