PainNCT05145595
Pain Sensitivity During Puberty
A study testing Thermal Sensory Analyzer, Pressure Stimuli and Mechanical Stimuli in people with Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Aim 1- To examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status Aim 2- To determine the relationships between sex hormone levels and pain sensitivity Exploratory Aim 1- To determine the effect of pubertal maturation on pain sensitivity Exploratory Aim 2- To identify… Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Thermal Sensory Analyzer, Pressure Stimuli and Mechanical Stimuli
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 17 Jul 2024
- Phase
- Interventional
- 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy males and females
- 9-16 years old
- English speakers
Who cannot join
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy
- Chronic Pain or frequent headaches (>5 headache /month)
- Psychiatric or neurological disorders
- Lack of sensation in the testable limb
- Disorders associated with pubertal maturation or usage of contraceptive pills that affect sex hormone levels
- Regular use of pain medications (e.g., opioids, antidepressants).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Effect of Puberty on Pain Sensitivity
Aim 1- To examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status Aim 2- To determine the relationships between sex hormone levels and pain sensitivity Exploratory Aim 1- To determine the effect of pubertal maturation on pain sensitivity Exploratory Aim 2- To identify parameters related to who will develop chronic pain during puberty
Hypothesis 1- Adolescents in early pubertal status will have higher pain ratings and lower pain modulation capabilities compared to adolescents in mid puberal status.
Read more
Hypothesis 2- Pain sensitivity will be associated with sex hormone levels. Exploratory Hypothesis 1- As adolescents mature, they will have a decrease in pain sensitivity to experimental pain which will be related to changes in sex hormone levels.
Exploratory hypothesis 2- Female adolescents with greater pain sensitivity, lower testosterone levels and with a family history of pain would be at a higher risk to develop chronic pain
Read the detailed description
At baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires.
In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only).
- Conditions
- Pain
- Being tested
- Thermal Sensory Analyzer, Pressure Stimuli, Mechanical Stimuli, Pain Ratings, Thermal pain thresholds
- Keywords
- Pain, Puberty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Sensory AnalyzerDevice
Thermal stimuli: The Thermal Sensory Analyzer (TSA-II or PATHWAY platform - Medoc, Ramat Yishai, Israel) will be used to deliver heat and cold stimuli. These devices can deliver relatively complex stimuli via computer control. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water container or a water bath (FISHER, USA). Participants will be free to pull out of the water bath at any time.
Pressure StimuliDevice
Pressure stimuli: Pressure stimuli will be applied by using a handheld algometer (Wagner Instruments) or the Pressure Algometer (Medoc, Ramat Yishai, Israel). These devices have a round probe that allows quantifying the amount of pressure that is being applied. The Pressure Algometer allows a real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.
Mechanical StimuliDevice
Mechanical stimuli: A set of standardised von Frey filaments (0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128 and 256mN). The contact area of the hairs with the skin is of uniform size (<1 mm²) and texture.
Pain RatingsBehavioural
Pain intensity and pain unpleasantness ratings will be assessed by numerical rating scale (ranging from 0- no pain/unpleasantness to- 100 the most intense/unpleasantness pain imaginable) and by mechanical and computerized visual analog scales (VAS which ranges between ''no pain sensation'' and ''most intense pain imaginable'').
Thermal pain thresholdsBehavioural
Cold and heat pain thresholds (CPT and HPT, respectively) will be determined [22; 55]. Thresholds are determined by continuous ramping of temperature from 32°C baseline temperature until the participant press a button at the first moment he/she feels pain from the stimulus. Cut-off temperatures are 0°C and 50°C, to minimize potential damage to the skin. The baseline temperature to which the thermode returns before each test is 32°C. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements.
Pressure pain thresholds (PPT)Behavioural
Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements.
Mechanical temporal summationBehavioural
A pinprick stimulus with standardised intensity (#6.10 or #6.45 von Frey filament) and a flat contact area of 0.25mm diameter will be used. In this test, participants will rate the pain evoked by a single pinprick stimulus and by a series of 10 identical pinprick stimuli. The 10 identical pinprick stimuli are applied with a frequency of 1 s-1 within an area of 1 cm2. Immediately following the single stimulus and series of stimuli, an evaluation of the pain will be collected. The difference in pain ratings evoked with the one stimuli vs. the 10 stimuli is the temporal summation value.
Conditioned pain modulation (CPM) efficiencyBehavioural
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information. CPM testing includes the application of a "test" stimulus without conditioning (control run) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run). Heat-CPM and pressure-CPM. Heat and pressure CPM will be tested in random order.
The difference between the pain ratings/thresholds of the test stimulus with vs. without the concomitant conditioning stimulus is the CPM magnitude. CPM<0 (reduction in pain) implies efficient inhibitory pain modulation of spatial filtering.
Offset analgesia efficiencyBehavioural
Offset analgesia (OA) paradigm assesses endogenous inhibitory pain modulation efficiency of temporal filtering of nociceptive information. The mechanisms underlying OA are distinct from the CPM mechanisms [41]. OA is characterized by a disproportionately large reduction in pain perception after a small decrease in temperature during noxious thermal stimulation.
Offset analgesia will be assessed using the three-temperature method (T1°C 5s, T1+1°C 5s, T1°C 20s). The T1 will be noxious heat (44-48°C) delivered to the hand or leg. During the OA paradigm, real time pain intensity ratings will be obtained using the computerized VAS.
The difference between the pain ratings of the 10-20 seconds noxious stimulus in the OA paradigm compared to a control paradigm (30 seconds of T1) is the OA magnitude. OA<0 (reduction in pain) implies efficient inhibitory pain modulation of temporal filtering.
Cold pain toleranceBehavioural
Cold pain tolerance will be assessed by having participants immerse their hand or foot in a cold (4-12°C) water bath. Tolerance will be defined by the time of hand withdrawal. VAS ratings of cold pain intensity might be obtained periodically, and both pain intensity and pain unpleasantness will be recorded upon hand withdrawal. Limb immersion in the cold water bath will be terminated after 120 s if participants do not withdraw their hand before then.
| Study group | Role | What they receive |
|---|---|---|
| Psychophysical assessments of experimental pain | Experimental | At baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires.
In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only). Receives: Device: Thermal Sensory Analyzer; Device: Pressure Stimuli; Device: Mechanical Stimuli; Behavioral: Pain Ratings; Behavioral: Thermal pain thresholds; Behavioral: Pressure pain thresholds (PPT); Behavioral: Mechanical temporal summation; Behavioral: Conditioned pain modulation (CPM) efficiency; Behavioral: Offset analgesia efficiency; Behavioral: Cold pain tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain ratings for heat stimuli
A 30-second tonic heat pain at the intensity of 46°C will be delivered to the volar forearm. During the heat stimulus, pain intensity ratings will be obtained.
Measured: 3 years
Pain ratings for cold stimuli
Immersion of the foot into a cold water bath (8°C). Pain ratings of the water immersion will be collected at the end of the immersion.
Measured: 3 years
Conditioned pain modulation
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information. CPM testing includes the application of a "test" stimulus without conditioning (control run) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run). The difference in pain sensitivity between the control and the conditioning run is the CPM response The test stimulus will be A 30-second tonic heat pain at the intensity of 46°C will be delivered to the volar forearm, and pressure pain thresholds at the trapezius.
The conditioning stimulus will be immersion of the foot into a cold water bath (8°C). Pain ratings of the water immersion will be collected at the end of the immersion.
Measured: 3 years
Testosterone levels
A blood draw will be collected, and total testosterone levels will be analyzed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start20 Sep 2022
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadas Nahman-Averbuch, Washington University School of Medicine
- Investigators
- Hadas Nahman-Averbuch, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145595
- Sponsor's protocol ID
- 202109120
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Puberty on Pain Sensitivity
- ClinicalTrials.gov ID
- NCT05145595
- Acronym / sponsor ID
- 202109120
- Conditions
- Pain
- Keywords
- Pain, Puberty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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.
Aim 1- To examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status Aim 2- To determine the relationships between sex hormone levels and pain sensitivity Exploratory Aim 1- To determine the effect of pubertal maturation on pain sensitivity Exploratory Aim 2- To identify parameters related to who will develop chronic pain during puberty
Hypothesis 1- Adolescents in early pubertal status will have higher pain ratings and lower pain modulation capabilities compared to adolescents in mid puberal status.
Hypothesis 2- Pain sensitivity will be associated with sex hormone levels. Exploratory Hypothesis 1- As adolescents mature, they will have a decrease in pain sensitivity to experimental pain which will be related to changes in sex hormone levels.
Exploratory hypothesis 2- Female adolescents with greater pain sensitivity, lower testosterone levels and with a family history of pain would be at a higher risk to develop chronic pain
Detailed description
At baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires.
In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychophysical assessments of experimental pain | Experimental | Device: Thermal Sensory Analyzer, Device: Pressure Stimuli, Device: Mechanical Stimuli, Behavioral: Pain Ratings, Behavioral: Thermal pain thresholds, Behavioral: Pressure pain thresholds (PPT), Behavioral: Mechanical temporal summation, Behavioral: Conditioned pain modulation (CPM) efficiency, Behavioral: Offset analgesia efficiency, Behavioral: Cold pain toleranceAt baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires. In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only). |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy males and females
- 9-16 years old
- English speakers
Key exclusion criteria (7 listed)
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy
- Chronic Pain or frequent headaches (>5 headache /month)
- Psychiatric or neurological disorders
- Lack of sensation in the testable limb
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 |
|---|---|---|
| Thermal Sensory AnalyzerThermal stimuli: The Thermal Sensory Analyzer (TSA-II or PATHWAY platform - Medoc, Ramat Yishai, Israel) will be used to deliver heat and cold stimuli. These devices can deliver relatively complex stimuli via computer control. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water container or a water bath (FISHER, USA). Participants will be free to pull out of the water bath at any time. | Device | Psychophysical assessments of experimental pain |
| Pressure StimuliPressure stimuli: Pressure stimuli will be applied by using a handheld algometer (Wagner Instruments) or the Pressure Algometer (Medoc, Ramat Yishai, Israel). These devices have a round probe that allows quantifying the amount of pressure that is being applied. The Pressure Algometer allows a real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius. | Device | Psychophysical assessments of experimental pain |
| Mechanical StimuliMechanical stimuli: A set of standardised von Frey filaments (0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128 and 256mN). The contact area of the hairs with the skin is of uniform size (<1 mm²) and texture. | Device | Psychophysical assessments of experimental pain |
| Pain RatingsPain intensity and pain unpleasantness ratings will be assessed by numerical rating scale (ranging from 0- no pain/unpleasantness to- 100 the most intense/unpleasantness pain imaginable) and by mechanical and computerized visual analog scales (VAS which ranges between ''no pain sensation'' and ''most intense pain imaginable''). | Behavioural | Psychophysical assessments of experimental pain |
| Thermal pain thresholdsCold and heat pain thresholds (CPT and HPT, respectively) will be determined [22; 55]. Thresholds are determined by continuous ramping of temperature from 32°C baseline temperature until the participant press a button at the first moment he/she feels pain from the stimulus. Cut-off temperatures are 0°C and 50°C, to minimize potential damage to the skin. The baseline temperature to which the thermode returns before each test is 32°C. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements. | Behavioural | Psychophysical assessments of experimental pain |
| Pressure pain thresholds (PPT)Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements. | Behavioural | Psychophysical assessments of experimental pain |
| Mechanical temporal summationA pinprick stimulus with standardised intensity (#6.10 or #6.45 von Frey filament) and a flat contact area of 0.25mm diameter will be used. In this test, participants will rate the pain evoked by a single pinprick stimulus and by a series of 10 identical pinprick stimuli. The 10 identical pinprick stimuli are applied with a frequency of 1 s-1 within an area of 1 cm2. Immediately following the single stimulus and series of stimuli, an evaluation of the pain will be collected. The difference in pain ratings evoked with the one stimuli vs. the 10 stimuli is the temporal summation value. | Behavioural | Psychophysical assessments of experimental pain |
| Conditioned pain modulation (CPM) efficiencyThe CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information. CPM testing includes the application of a "test" stimulus without conditioning (control run) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run). Heat-CPM and pressure-CPM. Heat and pressure CPM will be tested in random order. The difference between the pain ratings/thresholds of the test stimulus with vs. without the concomitant conditioning stimulus is the CPM magnitude. CPM<0 (reduction in pain) implies efficient inhibitory pain modulation of spatial filtering. | Behavioural | Psychophysical assessments of experimental pain |
| Offset analgesia efficiencyOffset analgesia (OA) paradigm assesses endogenous inhibitory pain modulation efficiency of temporal filtering of nociceptive information. The mechanisms underlying OA are distinct from the CPM mechanisms [41]. OA is characterized by a disproportionately large reduction in pain perception after a small decrease in temperature during noxious thermal stimulation. Offset analgesia will be assessed using the three-temperature method (T1°C 5s, T1+1°C 5s, T1°C 20s). The T1 will be noxious heat (44-48°C) delivered to the hand or leg. During the OA paradigm, real time pain intensity ratings will be obtained using the computerized VAS. The difference between the pain ratings of the 10-20 seconds noxious stimulus in the OA paradigm compared to a control paradigm (30 seconds of T1) is the OA magnitude. OA<0 (reduction in pain) implies efficient inhibitory pain modulation of temporal filtering. | Behavioural | Psychophysical assessments of experimental pain |
| Cold pain toleranceCold pain tolerance will be assessed by having participants immerse their hand or foot in a cold (4-12°C) water bath. Tolerance will be defined by the time of hand withdrawal. VAS ratings of cold pain intensity might be obtained periodically, and both pain intensity and pain unpleasantness will be recorded upon hand withdrawal. Limb immersion in the cold water bath will be terminated after 120 s if participants do not withdraw their hand before then. | Behavioural | Psychophysical assessments of experimental pain |
Primary outcome
Pain ratings for heat stimuli
Time frame: 3 years
A 30-second tonic heat pain at the intensity of 46°C will be delivered to the volar forearm. During the heat stimulus, pain intensity ratings will be obtained.
Pain ratings for cold stimuli
Time frame: 3 years
Immersion of the foot into a cold water bath (8°C). Pain ratings of the water immersion will be collected at the end of the immersion.
Conditioned pain modulation
Time frame: 3 years
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information. CPM testing includes the application of a "test" stimulus without conditioning (control run) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run). The difference in pain sensitivity between the control and the conditioning run is the CPM response The test stimulus will be A 30-second tonic heat pain at the intensity of 46°C will be delivered to the volar forearm, and pressure pain thresholds at the trapezius. The conditioning stimulus will be immersion of the foot into a cold water bath (8°C). Pain ratings of the water immersion will be collected at the end of the immersion.
Testosterone levels
Time frame: 3 years
A blood draw will be collected, and total testosterone levels will be analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Hadas Nahman-Averbuch, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Sensory Analyzer, Pressure Stimuli and Mechanical Stimuli in people with Pain, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jan 2026. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain ratings for heat stimuli (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.