Effects of Pregabalin on Mechanical Hyperalgesia
4 other identifiers
interventional
120
1 country
17
Brief Summary
The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick). The hypothesis is that in the placebo group the amount of non-responders is increased.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2006
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2006
CompletedFirst Posted
Study publicly available on registry
April 4, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedApril 5, 2007
April 1, 2006
April 3, 2006
April 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick)
Secondary Outcomes (15)
Degree of mechanical hyperalgesia
Ongoing pain (numerical rating scale)
Neuropathic Pain Symptom Inventory score
Additional QST (qualitative sensory testing) variable CDT = cold detection threshold,
Additional QST (qualitative sensory testing) variable HDT = heat detection threshold
- +10 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Recruitment:
- Age above 18 years;
- Neuropathic pain of at least 4/10 for at least 6 months;
- Mechanical hyperalgesia;
- One of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia;
- No nerve block or other interventional treatment for at least 4 weeks;
- Constant medication for at least 4 weeks;
- Signed informed consent;
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
- Enrolment open titration:
- Relevant mechanical hyperalgesia: SRF affected/control at least 2.0 with a minimal SRF of 0.8.
- Enrolment double-blind phase:
- At least 30% reduction in mechanical hyperalgesia (SRF) in the open titration;
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
- +1 more criteria
You may not qualify if:
- Anaphylaxis on the active component or any other component of Lyrica or the placebo (Lyrica®: pregabalin, lactose-monohydrate, corn starch, talcum; capsule shells: gelatine, titanium dioxide (E 171), natriumdodecylsulfat, high dispersive siliciumdioxide, purified water; ink: shellac, black iron(II,III)-oxide (E 172), propyleneglycol, kaliumhydroxide; additionally in placebo: microcrystalline cellulose, sucrose octaacetate, magnesium stearate)
- Intake of gabapentin or pregabalin within the last 4 weeks prior to recruitment
- Any surgery within the last two months or any scheduled surgery within the study period (20 weeks);
- Concurrent unstable disease involving any system, e.g. advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would deem the patient unsuitable for the study;
- History of cerebral vascular or other cerebral disease;
- Concurrent chronic or acute pain of other origin (osteoarthritis), which is not treated effectively
- Concurrent severe mental deficit, e.g. psychiatric disorders as defined by DSM IV including schizophrenia, mood disorders, organic brain syndrome, psychotic/delusional disorders, serious psychosis;
- Concurrent serious neurological disease, e.g. dementia, multiple sclerosis, or any other disease that would have impact on the ability of the patient to give their consent for the participation in the study or influences the pain perception;
- Concurrent atrioventricular block second degree or higher
- Concurrent renal failure (CLcr \< 30 ml/min)
- Concurrent hereditary galactose-intolerance
- Concurrent lapp-lactase insufficiency
- Concurrent glucose-galactose-malabsorption
- Concurrent sub-optimal stabilized Diabetes Mellitus (Hb1Ac \> 12%)
- Clinical apparent overdosage of opioids or psychopharmaca
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Berufsgenossenschaftliche Kliniken Bergmannsheil, Dept. of Anaesthesiology, Intensive Care and Pain Therapy, Dept. of Pain Therapy
Bochum, 44789, Germany
Pain Therapy, Dept. of Anaesthesiology and Intensive Care Medicine, University of Cologne
Cologne, 50924, Germany
University Hospital of Duesseldorf, Dept. of Paintherapy, Dept. of Anaesthesiology
Düsseldorf, 40225, Germany
Dept. of Anaesthesiology, University Hospital of Erlangen
Erlangen, 91054, Germany
Insitute of Physiology and Experimental Pathophysiology
Erlangen, 91054, Germany
Neurological University Hospital, University of Freiburg
Freiburg im Breisgau, 79106, Germany
Dept. of Neuroradiology, Neurological Health Care Center, University Hospital of Heidelberg
Heidelberg, 69120, Germany
Dept. of Neurology, Neurological Section, Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Health Care Centre, Dept. of Neurology, Johannes Gutenberg University of Mainz
Mainz, 55101, Germany
DRK - Pain Centre Mainz
Mainz, 55131, Germany
Pain Therapy, Dept. of Anaestesiology and Intensive Care Medicine, Clinical Medicine Mannheim, University of Heidelberg
Mannheim, 68167, Germany
Interdisciplinary Dept. of Pain Management, Dept. of Anaesthesiology, Ludwig-Maximilians-University
Munich, 81377, Germany
Dept. of Neurology, Universtity Hospital TU Munich
Munich, 81675, Germany
Anesthesiology and Surgical Intensive Care Medicine, University of Muenster
Münster, 48149, Germany
Dept. of Anaesthesia and Transfusion Medicine, University of Tuebingen
Tübingen, 72076, Germany
Dept. of Neurology, University of Ulm
Ulm, 89075, Germany
Neurological Hospital, University of Wuerzburg
Würzburg, 97080, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Maier, Prof. MD.
Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 3, 2006
First Posted
April 4, 2006
Study Start
July 1, 2006
Study Completion
April 1, 2008
Last Updated
April 5, 2007
Record last verified: 2006-04