PainPhase 1NCT01615510
Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models
A Phase 1 study testing Tapentadol immediate release in people with Pain and Hyperalgesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Hyperalgesia, Allodynia
- What is being tested?
- Tapentadol immediate release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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
- Administration of a monoaminoxidase-inhibitor (MAO-Inhibitor) within 14 days prior to recruitment visit.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Pain, Hyperalgesia, Allodynia
- Being tested
- Tapentadol immediate release, placebo
- Medical subject headings
- Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol immediate releaseDrug
Also called Palexia IR
100 mg, single administration
placeboDrug
Also called P Lichtenstein
placebo, single administration
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin (topical) | Experimental | 300 µL of 0.6% capsaicin in 45% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo Receives: Drug: Tapentadol immediate release; Drug: placebo |
| Menthol (topical) | Experimental | 1000 µL of 40% menthol in 90% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo Receives: Drug: Tapentadol immediate release; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: period 1 - period 2 (approx. 18 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralf Baron, University Hospital Schleswig-Holstein
- Investigators
- Ralf Baron, Professor, Principal investigator, Head of Division of Neurological Pain Research and Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615510
- Sponsor's protocol ID
- TapCapMentho01
- Status last verified
- Sep 2022
- First submitted
- 6 Jun 2012
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27295489
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01615510
- Acronym / sponsor ID
- TapCapMentho01
- Conditions
- Pain, Hyperalgesia, Allodynia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin (topical) | Experimental | Drug: Tapentadol immediate release, Drug: placebo300 µL of 0.6% capsaicin in 45% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo |
| Menthol (topical) | Experimental | Drug: Tapentadol immediate release, Drug: placebo1000 µL of 40% menthol in 90% ethanol, topically applied on the forearm intervention: tapentadol immediate release or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapentadol immediate releaseAlso: Palexia IR100 mg, single administration | Drug | Capsaicin (topical), Menthol (topical) |
| placeboAlso: P Lichtensteinplacebo, single administration | Drug | Capsaicin (topical), Menthol (topical) |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Derived from this study: PubMed 27295489Forster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Baron, Professor principal investigator
Head of Division of Neurological Pain Research and Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tapentadol immediate release in people with Pain and Hyperalgesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QST parameters (time frame: period 1 - period 2 (approx. 18 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.