Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain

NCT00961194 | Completed Phase 2

• 2 other identifiers: 0730102AOL 2007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuropathic Pain

Keywords

Ketamine; pain; neuropathic pain; chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Secondary Outcomes (1)

• 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

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

Study Arms (4)

placebo

PLACEBO COMPARATOR

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.

Drug: Ketamine

dose of ketamine tested = 0.35 mg/kg

EXPERIMENTAL

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.

Drug: Ketamine

dose of ketamine tested = 0.7 mg/kg

ACTIVE COMPARATOR

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.

Drug: Ketamine

dose of ketamine tested = 1.4 mg/kg

ACTIVE COMPARATOR

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.

Drug: Ketamine

Interventions

Ketamine DRUG

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.

Also known as: Ketamine PANPHARMA

dose of ketamine tested = 0.35 mg/kg; dose of ketamine tested = 0.7 mg/kg; dose of ketamine tested = 1.4 mg/kg; placebo

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service de Neurochirurgie

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neuralgia; Pain; Bronchiolitis Obliterans Syndrome

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nathalie Cantagrel, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

FR (1)