Primary Objective* Investigate the feasibility, applicability, safety, tolerability, and reproducibility of nociceptive tests in healthy volunteers.Secondary Objectives* Investigation of confounding factors including fear of pain, mood, age and…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoints
* Pain threshold and tolerance levels for each nociceptive test: pressure
pain (muscle) (kPa), electrical pain (skin) (mA), cold pressor pain (sec).
Secondary outcome
Secondary study endpoints
* Continuous VAS of pain intensity.
* McGill Pain Questionnaire Scores.
* STAI-DY1 scores.
Background summary
Pharmaceutical science continues to search for suitable biomarkers that can
assist in predicting the therapeutic potential of analgesic medication and
therefore, it*s efficacy in its target population. Data intensive, early-phase
studies provide a valuable opportunity that can offer this translational
information. A series of nociceptive pain tests early in drug development could
be used to:
* bridge findings in the laboratory and those in the clinical situation,
* provide valuable information in regard to the mechanism of action of a new
drug,
* predict most applicable patient population to be studied, and
* ascertain the most relevant nociceptive test for more intensive PK/PD
modeling.
The need to use a comprehensive battery of pain models is highlighted by
studies whereby only a single pain model, thought to relate to the clinical
situation, demonstrates lack of efficacy. No single experimental model can
replicate the complex nature of clinical pain (1). Therefore, one experimental
pain model cannot be used exclusively to screen the pharmacological action of a
compound. Therefore, the objective of this protocol will be to integrate a
range of tests such that they can be used as a combined screening tool for
early drug development.
Study objective
Primary Objective
* Investigate the feasibility, applicability, safety, tolerability, and
reproducibility of nociceptive tests in healthy volunteers.
Secondary Objectives
* Investigation of confounding factors including fear of pain, mood, age and
subject sex.
* Explore logistics, practicalities, and potential refinement of techniques.
* Comparison to historical data, with particular reference to the impact that
multiple nociceptive tests have on each other.
* Investigate two types of electrodes impact on electrical stimulation task
endpoints.
Study design
This is a validation study and will consist of two study visits as outlined in
the study schedule (see table 1), both starting at the same time of the day (±
2 hours). The schedule of the pain tests, in both frequency and duration, are
representative of a typical exploratory study investigating an oral analgesic.
Being exploratory in nature no formal power analysis will be performed.
However, to duplicate a typical early phase study, 20 subjects in total will be
tested. Precision data will be used to determine sample sizes for future
studies.
Study burden and risks
During and after the tests subjects can possibly feel pain and discomfort
because of exposure to a few stimulations.
Zernikedreef 10
2333 CL Leiden
NL
Zernikedreef 10
2333 CL Leiden
NL
Listed location countries
Age
Inclusion criteria
Subject:
* Agree to and be capable of signing an informed consent form.
* Healthy male and female subjects;
* Age: 18 to 65 years at screening (inclusive);
* Body mass index between 18-30 kg*m-2 (inclusive);
* Able to refrain from strenuous physical exercise from 48 hours prior to each nociceptive test until dismissal from the CHDR clinic;
* Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
* Ability to communicate well with the investigator in the Dutch language.
* Ability for female subjects to attend study days while in the follicular phase (3-13 days after onset of menstruation).
Exclusion criteria
* Legal incapacity or inability to understand or comply with the requirements of the study;
* Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (paraesthesia, etc.);
* Pregnancy
* History or clinical evidence of alcoholism or drug abuse;
* Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments;
* Use of over-the-counter medications within 3 days of nociceptive assessments.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32572.058.10 |