Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01615510
Other study ID # TapCapMentho01
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 2012
Est. completion date March 2013

Study information

Verified date September 2022
Source University Hospital Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tapentadol immediate release
100 mg, single administration
placebo
placebo, single administration

Locations

Country Name City State
Germany Department of Neurology Kiel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary QST parameters The primary objective is to evaluate the antihyperalgesic effect of a single dose of Tapentadol immediate release (IR) in two human experimental models:
cold pain threshold (menthol only),
heat pain thresholds (capsaicin only),
mechanical pain threshold
mechanical pain sensitivity,
dynamic mechanical allodynia,
area of dynamic mechanical allodynia and
area of pinprick-hyperalges
period 1 - period 2 (approx. 18 days)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care