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

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ClinicalTrials.gov Identifier: NCT00961194
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE August 17, 2009
First Posted Date  ICMJE August 18, 2009
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE March 2009
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
Official Title  ICMJE Evaluation of the Analgesic Effect of Orally Administrated Ketamine in Peripheral Neuropathic Pain Disease: Comparison of Three Doses Versus Placebo.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Drug: 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 Name: Ketamine PANPHARMA
Study Arms  ICMJE
  • Placebo Comparator: 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.

    Intervention: Drug: Ketamine
  • Experimental: 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.

    Intervention: Drug: Ketamine
  • Active Comparator: 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.

    Intervention: Drug: Ketamine
  • Active Comparator: 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.

    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2009)
30
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00961194
Other Study ID Numbers  ICMJE 0730102
AOL 2007 ( Other Identifier: AOL 2007 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nathalie Cantagrel, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP