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Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181012
First Posted: September 16, 2005
Last Update Posted: September 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.

Condition Intervention Phase
Cancer Pain Drug: Lidocaine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old) [ Time Frame: continuous intravenous perfusion for 6 days ]

Secondary Outcome Measures:
  • To confirm the tolerance of the lidocaine

Estimated Enrollment: 100
Study Start Date: May 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
  • Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
  • Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
  • Pain resistant to morphinic treatment

Exclusion Criteria:

  • Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
  • Neurological: non-controlled epilepsy, encephalopathy, or dementia
  • Severe hepatic insufficiency
  • Severe renal insufficiency
  • Respiratory insufficiency
  • Patients having surgery or in postoperative period
  • Known deficit in G6PD, alanine exposure, or sulphamide treatment
  • Porphyria
  • Weight > 80 kg
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181012


Contacts
Contact: Philippe Poulain, MD 33 1 42 11 40 53 poulain@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94800
Contact: Philippe Poulain, MD    33 1 42 11 40 53    poulain@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Philippe Poulain, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

ClinicalTrials.gov Identifier: NCT00181012     History of Changes
Other Study ID Numbers: LIDODOULABDO
CSET 2003/1054
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 19, 2007
Last Verified: September 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Cancer Related Visceral Pain Resistant to Morphinics

Additional relevant MeSH terms:
Visceral Pain
Nociceptive Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action


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