Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00961194
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:
NCT00961194
Study Brief:
Protocol Section:
NCT00961194