Pharmacological modulation of heterosynaptic LOng-TErm POtentiation in humans by ONdansetron and DExtromethorphan
| ISRCTN | ISRCTN38944269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38944269 |
| Protocol serial number | Tr 236/16-2/LTP-Ondan-Dex |
| Sponsor | Individual Sponsor (Germany) |
| Funder | The study is supported by a grant from the German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) (Grant: Tr236/16-2) |
- Submission date
- 03/11/2006
- Registration date
- 04/01/2007
- Last edited
- 04/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rolf-Detlef Treede
Scientific
Scientific
Institute of Physiology and Pathophysiology
Johannes Gutenberg-University Mainz
Duesbergweg 6
Mainz
55128
Germany
| treede@uni-mainz.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | The trial was designed as a double blind, randomised and placebo-controlled three-way cross-over study (Placebo-Dextromethrophan-Ondansetron). |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | LOTEPODEON (LOng-TErm POtentiation DExtromethorphan ONdansetron) |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Dextromethrophan and Ondansetron |
| Primary outcome measure(s) |
1. Spread of the area of dynamic allodynia and static hyperalgesia |
| Key secondary outcome measure(s) |
1. Anti-hyperalgesic effect to electrical and mechanical test stimuli |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Institute of Physiology and Pathophysiology
Mainz
55128
Germany
55128
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
