Influence on study outcomes of an inpatient trial by the behavior of the study staff – Placebo INfluence and Pain Outcome (PINgPOng) study
- Conditions
- Pain
- Registration Number
- DRKS00013586
- Lead Sponsor
- Phase I-Unit, Study Center Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 96
• Written informed consent of the subject
• Males and females aged between 18 and 60 (inclusive) years of age at the screening examination
• Healthy as determined by a responsible investigator based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range which seems irrelevant for the study objectives may be included in consultation with the Principal Investigator
• Subjects not giving written informed consent
• Subject who is unable to understand the nature, scope, significance and consequences of this clinical study
• Subjects who are not able to understand and communicate in the na-tive language
• Subjects incapable to follow study instructions, to comply with the requirements and restrictions listed in the consent form and to attend and complete all required visits
• Evidence of acute or ongoing severe infection
• Current chronic active disease (e. g. cardiac/pulmonary/liver/kidney/inflammatory/autoimmune diseases etc.) as assessed by the investigator
• Known hormonal disease
• History of a relevant psychiatric disease
• History of chronic pain experience
• History of any other relevant disease or condition that, in the opinion of the investigator puts the subject or the study results at unacceptable risk or may interfere with the study procedures and results or with the subject’s participation in this clinical study
• Relevant concomitant medication (hormones and systematic steroid therapy except contraceptive medication, psychiatric drugs etc.)
• Concomitant intake of the following substances in particular:
- analgesic medication except the study drug
- centrally active substances like sedatives, hypnotics, neuroleptics, antidepressives, antihistaminics and other opioids
- anticholinergic active drugs
- MAO inhibitors
- substances metabolized by Cytochrome P450 isoenzyme CYP2D6 and CYP3A4
- inducers of CYP2D6
- inhibitors of CYP2D6 (Paroxetine, Quinidin)
- inducers of CYP3A4 (Rifampicine, Carbamazepine, Phenytoin, St. John´s wort)
- inhibitors of CYP3A4 (makrolides, azol antimycotics, protease inhibitors, cimetidine, grapefruit)
• History of hypersensitivity to the study medication or intolerance of other opioid medication
• Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Very poor peripheral veins and pronounced fear of blood drawings
• BMI <18 or >30 kg/m2 (inclusive)
• History of abuse of medication, drugs or alcohol
• Simultaneously participation in any clinical study involving administration of an investigational medicinal product within 30 days prior to clinical study beginning
• Current pregnancy (positive pregnancy test) or nursing women
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the pain intensity of the perception of pain in the cold pressor test before and after administration of an analgesic medication (15 mg Oxycodon) or placebo measured by the area under the curve (AUC) of the visual analogue scale (VAS) in a usual study site environment (Arm A), after modification of the behavior of the study staff by training to optimize (Arm B) or to weaken (Arm C) analgesic therapy<br>
- Secondary Outcome Measures
Name Time Method Secondary objectives of this study are:<br>-Comparison of the of adverse effects of the study participants between the study arms (frequency of adverse events)<br>-Analysis of the predictability of effects by selected genotypes and neuroendocrine factors (Catechol-O-Methyltransferase (COMT Val158Met), µ-Opioid- Receptor))<br>-Analysis of the predictability of effects by characteristic traits anxiety, depression, stress (serum CRP, salivary Amylase, HADS, STADI, TICS questionnaires)<br>-Analysis of the predictability of effects by somatic reactions (blood pressure, heart rate)<br><br>