Contact information
Type
Scientific
Primary contact
Prof Rolf-Detlef Treede
ORCID ID
Contact details
Institute of Physiology and Pathophysiology
Johannes Gutenberg-University Mainz
Duesbergweg 6
Mainz
55128
Germany
treede@uni-mainz.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Tr 236/16-2/LTP-Ondan-Dex
Study information
Scientific title
Acronym
LOTEPODEON (LOng-TErm POtentiation DExtromethorphan ONdansetron)
Study hypothesis
Long-Term Potentiation (LTP) within the nociceptive system is one of the mechanisms underlying central sensitisation, which accounts for some hyperalgesic pain states in chronic pain patients. In the study we will use a human surrogate model of nociceptive LTP to study the involvement of NMDA-receptors and 5-HT3-receptors in the induction of hyperalgesia following high-frequency electrical stimulation of nociceptive afferents in the skin.
We will study the contribution of NMDA- and 5-HT3 receptors in plastic changes within the nociceptive system, which occur typically after a tissue injury, but in contrast to a real lesion we mimic an injury by high-frequency electrical stimulation of nociceptive afferents in the skin. This conditioning stimulation will lead to pain to light tactile stimuli (dynamic mechanical allodynia) and to an increase of pain to punctuate mechanical pain stimuli (static mechanical hyperalgesia). Both phenomena can typically been found in a subset of neuropathic pain patients.
Ethics approval
The study was approved by the local ethics committee (Ethikkommission der Landesärztekammer Rheinland-Pfalz; 15th March, 2003, reference number: 837.002.03(3664)) and was conducted in accordance with the declaration of Helsinki, the German Medicines Act (AMG), and the guidelines of the International Conference on Harmonisation (ICH) for Good Clinical Practice (GCP).
Study design
The trial was designed as a double blind, randomised and placebo-controlled three-way cross-over study (Placebo-Dextromethrophan-Ondansetron).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hyperalgesic pain states in chronic pain patients
Intervention
The effect of 150 mg dextromethorphan and 16 mg ondansetron orally (p.o.) will be compared to placebo in a three-way cross-over design. Sensory changes will be determined by Quantitative Sensory Testing (QST) using non-nociceptive and low-intensity painful mechanical and electrical stimuli.
Intervention type
Drug
Phase
Not Specified
Drug names
Dextromethrophan and Ondansetron
Primary outcome measures
1. Spread of the area of dynamic allodynia and static hyperalgesia
2. Combined analgesic and anti-hyperalgesic effect to mechancial and electrical stimuli on the site of conditioning stimulation
Secondary outcome measures
1. Anti-hyperalgesic effect to electrical and mechanical test stimuli
2. Analgesic effect to electrical and mechanical test stimuli
3. Anti-wind up
Overall trial start date
01/07/2005
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers of full age
2. Subject familiarised with the experimental procedure prior to experimentation and had given written informed consent
3. At least a 50% increase of pain to pinprick stimuli and a 25% increase of pain to electrical stimuli following high-frequency electrical stimulation in a screening visit
Participant type
Healthy volunteer
Age group
Adult
Gender
Not Specified
Target number of participants
18
Participant exclusion criteria
1. Skin lesions at the test and/or control site
2. Use of any medication within one day prior to study onset except contraceptives
3. Known hypersensitivity to histamine or to dextromethorphan and ondansetron and their derivates
4. Any history of allergy or drug hypersensitivity
5. Chronic use of analgesics or Central Nervous System (CNS) active drugs
6. Pregnancy or nursing
7. Any acute or chronic disease
Recruitment start date
01/07/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Institute of Physiology and Pathophysiology
Mainz
55128
Germany
Sponsor information
Organisation
Individual Sponsor (Germany)
Sponsor details
Prof. Dr. Rolf-Detlef Treede
Institute of Physiology and Pathophysiology
Johannes Gutenberg-University Mainz
Duesbergweg 6
Mainz
55128
Germany
+49 (0)61313925715
treede@uni-mainz.de
Sponsor type
Other
Website
Funders
Funder type
Research organisation
Funder name
The study is supported by a grant from the German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) (Grant: Tr236/16-2)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary