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

1 december 2014 uppdaterad av: University Hospital, Toulouse

Evaluation of the Analgesic Effect of Orally Administrated Ketamine in Peripheral Neuropathic Pain Disease: Comparison of Three Doses Versus Placebo.

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

22

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Toulouse, Frankrike, 31059
        • Service de Neurochirurgie

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 90 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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.
Läkemedel: 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.

Andra namn:
  • Ketamine PANPHARMA
Experimentell: 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.
Läkemedel: 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.

Andra namn:
  • Ketamine PANPHARMA
Aktiv komparator: 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.
Läkemedel: 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.

Andra namn:
  • Ketamine PANPHARMA
Aktiv komparator: 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.
Läkemedel: 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.

Andra namn:
  • Ketamine PANPHARMA

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: 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)
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)

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: Thermotest and hyperalgesia will be assessed at T0 and T1 hour, at visit 2 and visit 3
Thermotest and hyperalgesia will be assessed at T0 and T1 hour, at visit 2 and visit 3

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Toulouse

Utredare

  • Huvudutredare: Nathalie Cantagrel, MD, University Hospital, Toulouse

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2009

Primärt slutförande (Faktisk)

1 september 2013

Avslutad studie (Faktisk)

1 mars 2014

Studieregistreringsdatum

Först inskickad

17 augusti 2009

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2009

Första postat (Uppskatta)

18 augusti 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 december 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 december 2014

Senast verifierad

1 december 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0730102
  • AOL 2007 (Annan identifierare: AOL 2007)

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