NCT01615510

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

June 6, 2012

Last Update Submit

September 9, 2022

Conditions

PainHyperalgesiaAllodynia

Outcome Measures

Primary Outcomes (1)

  • 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: 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

    period 1 - period 2 (approx. 18 days)

Study Arms (2)

Capsaicin (topical)

EXPERIMENTAL

300 µL of 0.6% capsaicin in 45% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo

Drug: Tapentadol immediate releaseDrug: placebo

Menthol (topical)

EXPERIMENTAL

1000 µL of 40% menthol in 90% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo

Drug: Tapentadol immediate releaseDrug: placebo

Interventions

Tapentadol immediate releaseDRUG

100 mg, single administration

Also known as: Palexia IR
Capsaicin (topical)Menthol (topical)
placeboDRUG

placebo, single administration

Also known as: P Lichtenstein
Capsaicin (topical)Menthol (topical)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • History of orthostatic hypotension.
  • 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.
  • Pregnant or breastfeeding women.
  • Known or suspected of not being able to comply with procedures described in the trial protocol.
  • Not able to communicate meaningfully with the investigator and staff.
  • Preplanned surgery or procedures that would interfere with the conduct of the trial.
  • Acute skin disease, lesions, acute sunburn, extensive tattoos or scars at the forearm where the menthol / capsaicin application is planned.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Kiel, 24105, Germany

Location

Related Publications (1)

  • Forster M, Helfert S, Dierschke R, Grosskopf M, Hullemann P, Keller T, Baron R, Binder A. Evaluation of the antihyperalgesic effect of tapentadol in two human evoked pain models - the TapCapMentho pilot trial. Expert Opin Pharmacother. 2016 Sep;17(13):1717-25. doi: 10.1080/14656566.2016.1201071. Epub 2016 Aug 10.

    PMID: 27295489DERIVED

MeSH Terms

Conditions

PainHyperalgesia

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ralf Baron, Professor

    Head of Division of Neurological Pain Research and Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr., head of division of neurological pain research and therapy

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

DE(1)