CancerPhase 3NCT00181012
Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics
A Phase 3 study testing Lidocaine in people with Cancer and Pain, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- What is being tested?
- Lidocaine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known deficit in G6PD, alanine exposure, or sulphamide treatment
- Porphyria
- Weight > 80 kg
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Gustave-Roussy
Villejuif, 94800
Philippe Poulain, MD, 33 1 42 11 40 53, poulain@igr.fr
About this study
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
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.
- Being tested
- Lidocaine
- Keywords
- Cancer Related Visceral Pain Resistant to Morphinics
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: continuous intravenous perfusion for 6 days
Secondary outcomes (1)
To confirm the tolerance of the lidocaine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Poulain, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181012
- Sponsor's protocol ID
- LIDODOULABDO
- Other IDs
- CSET 2003/1054
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 19 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00181012
- Acronym / sponsor ID
- LIDODOULABDO
- Keywords
- Cancer Related Visceral Pain Resistant to Morphinics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- May 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine | Drug | – |
Primary outcome
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
1 secondary outcome
To confirm the tolerance of the lidocaine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Poulain, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine in people with Cancer and Pain, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Poulain, MD (33 1 42 11 40 53, poulain@igr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2007.