Neuropathic PainPhase 2KETACLUDNCT00961194
Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
A Phase 2 study testing Ketamine in people with Neuropathic Pain, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Uncontrolled arterial hypertension
- Recent cardio vascular accident
- Severe cardiac problems
- Drug abuse
- Psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Ketamine
- Keywords
- Ketamine, pain, neuropathic pain, chronic
- Medical subject headings
- Neuralgia, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine PANPHARMA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Thermotest and hyperalgesia will be assessed at T0 and T1 hour, at visit 2 and visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Cantagrel, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961194
- Sponsor's protocol ID
- 0730102
- Other IDs
- AOL 2007
- Acronym
- KETACLUD
- Status last verified
- Dec 2014
- First submitted
- 17 Aug 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of Orally Administrated Ketamine in Peripheral Neuropathic Pain Disease: Comparison of Three Doses Versus Placebo.
- ClinicalTrials.gov ID
- NCT00961194
- Acronym / sponsor ID
- KETACLUD / 0730102
- Conditions
- Neuropathic Pain
- Keywords
- Ketamine, pain, neuropathic pain, chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: KetamineThe 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. |
| dose of ketamine tested = 0.35 mg/kg | Experimental | Drug: KetamineThe 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. |
| dose of ketamine tested = 0.7 mg/kg | Active comparator | Drug: KetamineThe 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. |
| dose of ketamine tested = 1.4 mg/kg | Active comparator | Drug: KetamineThe 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketamine PANPHARMAInitial 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. | Drug | 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 |
Primary outcome
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.
Time frame: 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)
1 secondary outcome
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
Time frame: Thermotest and hyperalgesia will be assessed at T0 and T1 hour, at visit 2 and visit 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Cantagrel, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine in people with Neuropathic Pain, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.