Clinical trial: Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models (NCT01615510)

Eligibility criteria:
Inclusion Criteria:

          1. Provided written informed consent to participating in the trial.

          2. Caucasian, female or male, and aged 18 years to 55 years, inclusive.

          3. Body mass index between 18.5 kg/m2 and 30 kg/m2, inclusive, with a lower body weight
             limit of 50 kg.

          4. 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).

          5. 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.

          6. 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.

          7. Female subjects of childbearing potential must have a negative serum hCG test at the
             Enrollment Visit.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. Positive or missing drugs of abuse screening (alcohol breath test, urine screening
             test for drugs of abuse).

          4. Diseases or conditions known to interfere with the absorption, distribution,
             metabolism, or excretion of drugs.

          5. History or presence of severe respiratory depression with hypoxia and/or hypocapnia,
             severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma,
             paralytic ileus.

          6. 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).

          7. 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.

          8. History or presence of seizure disorder and/or epilepsy or any condition associated
             with a significant risk for seizure disorder or epilepsy.

          9. History of orthostatic hypotension.

         10. Blood donation or acute loss of blood (more than 100 mL) during the 1 month before the
             enrollment visit, or intention to donate blood or blood products during the trial or
             within 1 month following the completion of the trial.

         11. Pregnant or breastfeeding women.

         12. Known or suspected of not being able to comply with procedures described in the trial
             protocol.

         13. Not able to communicate meaningfully with the investigator and staff.

         14. Preplanned surgery or procedures that would interfere with the conduct of the trial.

         15. Acute skin disease, lesions, acute sunburn, extensive tattoos or scars at the forearm
             where the menthol / capsaicin application is planned.

         16. Employee of the Investigator or trial site, with direct involvement in the proposed
             trial or other trials under the direction of that Investigator or trial site, as well
             as family members of the employees or the Investigator

         17. Administration of a monoaminoxidase-inhibitor (MAO-Inhibitor) within 14 days prior to
             recruitment visit.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment