Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models (NCT01615510) | Clinical Trial Compass
TerminatedPhase 1
Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models
Germany24 participantsStarted 2012-10
Plain-language summary
MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation besides effectively reducing pain intensity in pain. Human pain surrogate models can serve in this proof-of-concept study to further elucidate this assumption.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Provided written informed consent to participating in the trial.
✓. Caucasian, female or male, and aged 18 years to 55 years, inclusive.
✓. Body mass index between 18.5 kg/m2 and 30 kg/m2, inclusive, with a lower body weight limit of 50 kg.
✓. In good health as determined by medical history, physical examination, 12-lead ECG, vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure), oxygen saturation, and laboratory monitoring (hematology, clinical chemistry, clotting, and urinalysis).
✓. Subjects must be able to feel thermal and mechanical sensation (cold, warm, sharp, unpleasant sensation) on normal skin (at the forearm intended for menthol / capsaicin administration) confirmed by routine neurological bed-side testing.
✓. Female subjects must be postmenopausal (with at least 2 years since last menstruation), surgically sterile (e.g., after hysterectomy or bilateral oophorectomy), or practicing an effective method of birth control (e.g., oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) at the Enrollment Visit and during the trial.
✓. Female subjects of childbearing potential must have a negative serum hCG test at the Enrollment Visit.
Exclusion criteria
✕. The subject has received any of the IMPs or used an investigational medical device within 30 days or within a period less than 10 times the half life of an investigational drug, whichever is longer, before the first dose of IMP is scheduled.
. History or presence of opioid abuse, drug abuse, or alcohol abuse or presence of an acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs.
✕. Positive or missing drugs of abuse screening (alcohol breath test, urine screening test for drugs of abuse).
✕. Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
✕. History or presence of severe respiratory depression with hypoxia and/or hypocapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
✕. History or presence of hypersensitivity to Tapentadol, menthol, capsaicin/chili peppers or any of the other excipients of the Palexia® IR (Tapentadol), menthol, or capsaicin formulations or to opioid antagonists (e.g., naloxone).
✕. Subjects who have used any prescribed and non-prescribed systemic or topical medication, except contraceptives, on a daily base within 14 days before the Enrolment Visit, or anticipated use from the Enrolment Visit until the first administration of the IMP.
✕. History or presence of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy.