Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
NCT ID: NCT00961194
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2009-03-31
2014-03-31
Brief Summary
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It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA) receptor may have been efficient in the treatment of neuropathic pain disorders.
Ketamine is the only NMDA receptor antagonist commercially available in France. Ketamine is usually administered intravenously for surgical anesthesia.
The intravenous administration of ketamine will be difficult to manage in the treatment of chronic neuropathic pain.
Some trials using oral ketamine for the treatment of neuropathic pain were conducted but results were heterogeneous. This may be explained by the different range of ketamine doses tested.
The aim of this clinical trial is to identify a safe and an efficient dose of orally administrated ketamine for the treatment of peripheral neuropathic pain.
The clinical trial will be conducted in Toulouse Hospital, France. This study is a randomized, double-blind, placebo-controlled trial. The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).
Detailed Description
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In this study, ketamine will be administrated during seven days, which will allow us to evaluate ketamine efficiency and safety.
The effect of ketamine on pain intensity will be mainly studied using a visual analogue scale (VAS) but also taking into account the score assigned by the patient to his pain. This score will be noted down by patients before, during and after ketamine treatment.
Evaluation of benefit/risk for ketamine administration during this trial, shows that even if adverse events are not excluded, the benefit for the patients may be neuropathic pain relief.
Because clinical current knowledge regarding oral administration of ketamine is limited, this trial intends to enlarge information about ketamine efficiency and safety, more particularly in neuropathic pain disorders.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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placebo
The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Ketamine
Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
* 0.35 mg/kg
* 0.7 mg/kg
* 1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
dose of ketamine tested = 0.35 mg/kg
The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Ketamine
Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
* 0.35 mg/kg
* 0.7 mg/kg
* 1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
dose of ketamine tested = 0.7 mg/kg
The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Ketamine
Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
* 0.35 mg/kg
* 0.7 mg/kg
* 1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
dose of ketamine tested = 1.4 mg/kg
The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Ketamine
Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
* 0.35 mg/kg
* 0.7 mg/kg
* 1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Interventions
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Ketamine
Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
* 0.35 mg/kg
* 0.7 mg/kg
* 1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pain score must be at least 40 mm in a VAS (reflecting pain intensity during the 7 days and the day before visit 1).
* Patients in which pain is not satisfactory relieved by level 1, 2 or 3 analgesic drugs (associated or not with antidepressants or antiepileptic drugs). Patients treated with level 2 or 3 analgesic drugs must stop these treatments one week before and during ketamine treatment.
* Patients must benefit from the French Social security system.
* Patients must be able to complete the tests.
* Patients must give a written informed consent.
* Patients must be aged from 30 to 90 years.
* Female fertile patients must use an efficient method of contraception.
Exclusion Criteria
* Pain score is less than 40 mm in a VAS (reflecting pain intensity during the 7 days and the day before visit 1).
* Patients not able to complete the tests.
* Patients not able to stop level 2 or 3 analgesic drugs.
* Patients in which ketamine is contraindicated:
* Hypersensibility to one of the compounds of the ketamine syrup
* Uncontrolled arterial hypertension
* Recent cardio vascular accident
* Severe cardiac problems
* Drug abuse
* Psychosis
30 Years
90 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Nathalie Cantagrel, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Service de Neurochirurgie
Toulouse, , France
Countries
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Other Identifiers
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AOL 2007
Identifier Type: OTHER
Identifier Source: secondary_id
0730102
Identifier Type: -
Identifier Source: org_study_id