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Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615510
Recruitment Status : Terminated
First Posted : June 8, 2012
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Ralf Baron, University Hospital Schleswig-Holstein

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Hyperalgesia Allodynia Drug: Tapentadol immediate release Drug: placebo Phase 1

Detailed Description:
To evaluate exploratory the antihyperalgesic effect of a single dose of Palexia® IR (Tapentadol) in two human experimental models of 1) cold and mechanical (pinprick) hyperalgesia after topical application of menthol at high-concentration [40%] and 2) of heat and mechanical (pinprick) hyperalgesia by topical applied capsaicin [0.6%] in comparison to placebo. Therefore, cold, heat and mechanical hyperalgesia and allodynia will be determined by parameters of the Quantitative Sensory Testing (QST). These parameters are cold and heat pain thresholds, mechanical pain threshold and sensitivity as well as dynamic mechanical allodynia. Further, the areas of dynamic mechanical allodynia and pinprick-hyperalgesia will be determined at each timepoint of QST-assessement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models of: 1) Cold and Mechanical Hyperalgesia Evoked by Topical High-concentration Menthol , 2) Heat and Mechanical Hyperalgesia by Capsaicin.
Study Start Date : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Capsaicin (topical)
300 µL of 0.6% capsaicin in 45% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo
Drug: Tapentadol immediate release
100 mg, single administration
Other Name: Palexia IR

Drug: placebo
placebo, single administration
Other Name: P Lichtenstein

Experimental: Menthol (topical)
1000 µL of 40% menthol in 90% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo
Drug: Tapentadol immediate release
100 mg, single administration
Other Name: Palexia IR

Drug: placebo
placebo, single administration
Other Name: P Lichtenstein

Primary Outcome Measures :
  1. QST parameters [ Time Frame: period 1 - period 2 (approx. 18 days) ]

    The primary objective is to evaluate the antihyperalgesic effect of a single dose of Tapentadol immediate release (IR) in two human experimental models:

    1. cold pain threshold (menthol only),
    2. heat pain thresholds (capsaicin only),
    3. mechanical pain threshold
    4. mechanical pain sensitivity,
    5. dynamic mechanical allodynia,
    6. area of dynamic mechanical allodynia and
    7. area of pinprick-hyperalges

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615510

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Department of Neurology
Kiel, Germany, 24105
Sponsors and Collaborators
University Hospital Schleswig-Holstein
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Principal Investigator: Ralf Baron, Professor Head of Division of Neurological Pain Research and Therapy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ralf Baron, Professor Dr., head of division of neurological pain research and therapy, University Hospital Schleswig-Holstein Identifier: NCT01615510    
Other Study ID Numbers: TapCapMentho01
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents