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

1 dicembre 2014 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

22

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Toulouse, Francia, 31059
        • Service de Neurochirurgie

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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.
Droga: 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.

Altri nomi:
  • Ketamine PANPHARMA
Sperimentale: 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.
Droga: 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.

Altri nomi:
  • Ketamine PANPHARMA
Comparatore attivo: 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.
Droga: 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.

Altri nomi:
  • Ketamine PANPHARMA
Comparatore attivo: 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.
Droga: 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.

Altri nomi:
  • Ketamine PANPHARMA

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Toulouse

Investigatori

  • Investigatore principale: Nathalie Cantagrel, MD, University Hospital, Toulouse

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2009

Completamento primario (Effettivo)

1 settembre 2013

Completamento dello studio (Effettivo)

1 marzo 2014

Date di iscrizione allo studio

Primo inviato

17 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

17 agosto 2009

Primo Inserito (Stima)

18 agosto 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0730102
  • AOL 2007 (Altro identificatore: AOL 2007)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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