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Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain

NCT00961194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-12-02

No results posted yet for this study

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).

Conditions

  • Neuropathic Pain

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Nathalie Cantagrel, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-09-30
Completion
2014-03-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961194 on ClinicalTrials.gov