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NCT00181012 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00181012
Other study ID # LIDODOULABDO
Secondary ID CSET 2003/1054
Status Recruiting
Phase Phase 3
First received September 13, 2005
Last updated September 18, 2007
Start date May 2005

Study information
Verified date September 2006
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Philippe Poulain, MD
Phone 33 1 42 11 40 53
Email poulain@igr.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine

Locations
Country Name City State
France Institut Gustave-Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) continuous intravenous perfusion for 6 days
Secondary To confirm the tolerance of the lidocaine
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