Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00961194
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT00961194
Study Brief:
Protocol Section:
NCT00961194