Condition category
Signs and Symptoms
Date applied
03/11/2006
Date assigned
04/01/2007
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes