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Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain (KETACLUD)

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ketamine
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathic Pain focused on measuring Ketamine, pain, neuropathic pain, chronic

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must suffer from peripheral neuropathic chronic pain.
  • 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:

  • Patients not suffering from peripheral neuropathic chronic pain.
  • 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

Sites / Locations

  • Service de Neurochirurgie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

placebo

dose of ketamine tested = 0.35 mg/kg

dose of ketamine tested = 0.7 mg/kg

dose of ketamine tested = 1.4 mg/kg

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of pain intensity using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain) before and after 7 days of oral administration of one of the three doses of ketamine or placebo.

Secondary Outcome Measures

Pain intensity will be evaluated by measuring thermal sensibility. A thermode will be used to determine the heat and cold pain thresholds (thermotest) and by measuring hyperalgesia

Full Information

First Posted
August 17, 2009
Last Updated
December 1, 2014
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00961194
Brief Title
Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
Acronym
KETACLUD
Official Title
Evaluation of the Analgesic Effect of Orally Administrated Ketamine in Peripheral Neuropathic Pain Disease: Comparison of Three Doses Versus Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain disease. 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
In previous studies, it was shown that when ketamine was administrated by the intravenous route, its analgesic action was rapid. In one study, when oral ketamine was administrated to patients suffering from neuropathic pain, in six out of nine patients, pain was relieved after 24 hours post-administration. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Ketamine, pain, neuropathic pain, chronic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
dose of ketamine tested = 0.35 mg/kg
Arm Type
Experimental
Arm Description
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.
Arm Title
dose of ketamine tested = 0.7 mg/kg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dose of ketamine tested = 1.4 mg/kg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine PANPHARMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of pain intensity using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain) before and after 7 days of oral administration of one of the three doses of ketamine or placebo.
Time Frame
V1 (14 days before ketamine treatment), at V2 (before oral administration of one of the three doses of ketamine or placebo), at V3 (after 7 days of oral administration), and at V4 (after 7 days of the end of treatment)
Secondary Outcome Measure Information:
Title
Pain intensity will be evaluated by measuring thermal sensibility. A thermode will be used to determine the heat and cold pain thresholds (thermotest) and by measuring hyperalgesia
Time Frame
Thermotest and hyperalgesia will be assessed at T0 and T1 hour, at visit 2 and visit 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must suffer from peripheral neuropathic chronic pain. 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: Patients not suffering from peripheral neuropathic chronic pain. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Cantagrel, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurochirurgie
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain

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