Condition category
Signs and Symptoms
Date applied
16/09/2010
Date assigned
08/12/2010
Last edited
08/12/2010
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

Department of Neurophysiology
Medical Faculty Mannheim of the University of Heidelberg
Centre for Biomedicine and Medical Technology Mannheim (CBTM)
Ludolf-Krehl-Str. 13 - 17
Mannheim
68167
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FLUCAP/KAD 162

Study information

Scientific title

Effect of flupirtine on experimental hyperalgesia in humans: a double-blind, placebo-controlled crossover trial

Acronym

Study hypothesis

Assessment of the effect of flupirtine versus placebo on acute pain (analgesia), secondary hyperalgesia, dynamic mechanical allodynia and wind up (pain summation) in healthy volunteers following intradermal capsaicin injection.

Ethics approval

The Medical Ethics Commission II, Medical Faculty Mannheim of the University of Heidelberg (Med. Ethikkommission II Medizinische Fakultät Mannheim der Universität Heidelberg) approved on the 31st May 2010 (ref: 2010-010F-MA/monozentrisch)
The trial will be 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

Single centre double blind randomised placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Normal skin sensitivity and experimentally-evoked hyperalgesia

Intervention

The effect of 4 x 400 mg (= 1600 mg) flupirtine retard (Trancolong®) applied over 4 days will be compared to placebo in a two-way cross-over design (placebo-flupirtine). Sensory changes in normal skin will be determined by Quantitative Sensory Testing (QST) using non-nociceptive and low-intensity painful mechanical and thermal stimuli, which were applied in runs alternating between two skin sites on the forearms (a test site and a control site). In addition, the effect of flupirtine versus placebo on experimental mechanical hyperalgesia, which will be induced by intradermal capsaicin injection (100 µg), will be determined.

Intervention type

Drug

Phase

Phase I

Drug names

Flupirtine (Trancolong®)

Primary outcome measures

Hierarchical approach
1. Combined analgesia and anti-hyperalgesia to pinpricks: pain at conditioned skin site (test site) analysed 0.5 - 1.5 hours after capsaicin injection. If present, then:
1.1. Analgesia to pinpricks: pain to pinpricks in unconditioned skin (control site) normalised to pre-capsaicin
1.2. Anti-hyperalgesia: pain to pinpricks at the test site relative to control site (ratio) normalised to pre-capsaicin

Secondary outcome measures

1. Size reduction of area of secondary hyperalgesia
2. Size reduction of area of dynamic mechanical allodynia
3. Size reduction of the flare area (peripheral flupirtine effect)
4. Analgesia to measures of painful thermal and chemical stimuli in unconditioned skin after drug application (QST profile)
5. Wind-up to painful mechanical stimuli

Overall trial start date

01/09/2010

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers, age 18 - 65 years
2. Negative pregnancy test (on day of respective visit, female)
3. Written informed consent
4. Clinical laboratory values within the normal range

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Any history of allergy or drug hypersensitivity
2. Any acute or chronic disease
3. Alcohol or drug abuse
4. Use of any medication within 1 day prior to study onset or, in case of any intake of medication during the last 6 weeks, the wash-out period prior to inclusion was at least less than 5 times the corresponding half-life of the medication taken (incl. dermatological applications; except contraceptives)
5. Dermatological, psychiatric or neurological disorder
6. Blood coagulation disorder
7. Chronic or severe liver disease (hep. encephalopathy, cholestase)
8. Myasthenia gravis
9. Acute or recently resolved tinnitus
10. Use of analgesics or CNS active drugs
11. Participation in any clinical study within 30 days prior to this study
12. Any relevant deviation in clinical or laboratory assessment
13. Known hypersensivity to flupirtine and its derivatives
14. Known hypersensitivity to histamine
15. Skin lesions at the test areas
16. Pregnant or nursing women

Recruitment start date

01/09/2010

Recruitment end date

28/02/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Neurophysiology,
Mannheim
68167
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

(represented by Dr. Marina Frost)
Ruprecht-Karls-Universität Heidelberg
Grabengasse 1
Heidelberg
69117
Germany

Sponsor type

University/education

Website

http://www.uni-heidelberg.de/index_e.html

Funders

Funder type

Industry

Funder name

Dr. Kade Pharmazeutische Fabrik GmbH (Germany) (FLUCAP/KAD162)

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