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Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD

Primary Purpose

Oropharyngeal Dysphagia, Swallowing Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Capsaicin
Piperine
Placebo
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Dysphagia focused on measuring TRP agonists, Sensory stimulation, Rehabilitation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥70 years With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia Penetration-aspiration scale >1 in videofluoroscopy Able to follow the protocol and to give written informed consent. Exclusion Criteria: Life expectancy < 3m or palliative care Allergy to iodinated contrast or to the components of the treatment solutions Cancer or active infection Implanted electronic device Epilepsy Metal in the head Participation in another clinical trial (previous month).

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Capsaicin

Piperine

Placebo

Arm Description

Natural TRPV1 agonist at a concentration of 10mcM. Posology: 10 mL every 8h for 6 month.

Natural TRPA1/V1 agonist at a concentration of 150mcM. Posology: 10 mL every 8h for 6 month.

Deionized water + the same preservatives as in the active treatments

Outcomes

Primary Outcome Measures

Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Severity of oropharyngeal dysphagia
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Safety impairment signs
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Efficacy impairment signs
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Swallow biomechanics
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Pharyngeal sensory evoked potential (pSEP)
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Pharyngeal motor evoked potentials (pMEP)
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).

Secondary Outcome Measures

Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography and accelerometry for 10min to assess: the number of swallows per minute
Clinical outcomes: Hospital readmission rate
Hospital readmissions (readmissions/100 persons-year)
Clinical outcomes: Prevalence of lower respiratory tract infections
Lower respiratory tract infections (including pneumonia)
Clinical outcomes: Mortality
Mortality rate
Responders rate
Responders were defined as those patients who, after treatment, achieved safe swallow at a lower level of viscosity or, at the same viscosity level, improved at least one point in the penetration-aspiration scale.
Treatment palatability: Taste
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the taste using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Treatment palatability: Texture
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the texture using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Treatment palatability: Future Adherence
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the possible future adherence to the treatment if prescribed using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Salivary neuropeptides
Saliva samples will be collected in all study visits using the Salivette® technique, by putting a swab under the tongue for 5 min. The concentration of salivary neuropeptides substance P (SP) and calcitonin gene-related peptide (CGRP) will be determined by using 2 specific commercial Enzyme-Linked ImmunoSorbent Assay (ELISA) kits
Treatment safety
Adverse events occurring during the study will be monitored according to the guideline of categories described by the world health organization
Treatment compliance
A sample of urine will be collected at each study visit and the concentration of riboflavin (part of the composition of the product from the 3 groups) will be extrapolated with fluorescence.

Full Information

First Posted
May 23, 2023
Last Updated
July 14, 2023
Sponsor
Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT05958173
Brief Title
Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD
Official Title
Biomechanical, Neurophysiological and Clinical Effects of 6-month Stimulation Using TRPV1 and TRPA1 Agonists in Older Patients With Oropharyngeal Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). The investigators have demonstrated the acute and sub-acute therapeutic effect of TRP agonists on mechanical and neural swallow responses in patients with OD. The present hypothesis is that 6-months treatment with TRPV1 (capsaicin) or TRPA1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. The aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (VFS), neurophysiology (pharyngeal evoked sensory potentials -pSEP- and motor evoked potentials -pMEP-), and clinical outcomes during a 6-month treatment with TRP agonists added to the alimentary bolus 3 times a day in older patients with OD. Design: 150 older patients (>70y) with OD will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µM (TRPV1 agonist), 2) piperine 150µM (TRPA1), and 3) placebo (Control), will be evaluated. Measurements: 1) VFS signs of swallowing safety and efficacy and timing of swallow response ; 2) Spontaneous swallowing frequency; 3) Latency, amplitude and cortical representation of pSEP and pMEP; 4) Concentration of substance P and CGRP in saliva, 5) Clinical outcomes (respiratory and nutritional complications). The results of this study will increase evidence for a new generation of pharmacological treatments for older patients with OD, moving from compensation to rehabilitation of the swallowing function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia, Swallowing Disorder
Keywords
TRP agonists, Sensory stimulation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, double-blinded, three-arm randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
The products will be prepared in the Pharmacy Department and will be labeled with a code that does not allow its identification neither by the patient nor by the investigator who administers it.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capsaicin
Arm Type
Active Comparator
Arm Description
Natural TRPV1 agonist at a concentration of 10mcM. Posology: 10 mL every 8h for 6 month.
Arm Title
Piperine
Arm Type
Active Comparator
Arm Description
Natural TRPA1/V1 agonist at a concentration of 150mcM. Posology: 10 mL every 8h for 6 month.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Deionized water + the same preservatives as in the active treatments
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsaicin
Intervention Description
Oral stimulation with natural TRPV1 agonist
Intervention Type
Dietary Supplement
Intervention Name(s)
Piperine
Intervention Description
Oral stimulation with natural TRPA1/V1 agonist
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Oral stimulation with placebo solution
Primary Outcome Measure Information:
Title
Severity of oropharyngeal dysphagia
Description
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time Frame
Pre treatment visit
Title
Severity of oropharyngeal dysphagia
Description
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time Frame
1 month follow-up visit
Title
Severity of oropharyngeal dysphagia
Description
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time Frame
3 month follow-up visit
Title
Severity of oropharyngeal dysphagia
Description
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: Material does not enter the airway. Material enters the airway. Remains above vocal cords and is ejected from the airway. Material is above vocal cords and is not ejected from the airway. Material enters the airway, contacts vocal cords and is ejected from the airway. Material contacts the vocal cords and is not ejected from the airway. Material passes below the vocal cords and is ejected into larynx or out of the airway. Material passes below the vocal cords and is not ejected from the trachea despite effort. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Time Frame
6 month follow-up visit
Title
Safety impairment signs
Description
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time Frame
Pre treatment visit
Title
Safety impairment signs
Description
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time Frame
1 month follow-up visit
Title
Safety impairment signs
Description
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time Frame
3 month follow-up visit
Title
Safety impairment signs
Description
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Time Frame
6 month follow-up visit
Title
Efficacy impairment signs
Description
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time Frame
Pre treatment visit
Title
Efficacy impairment signs
Description
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time Frame
1 month follow-up visit
Title
Efficacy impairment signs
Description
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time Frame
3 month follow-up visit
Title
Efficacy impairment signs
Description
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Time Frame
6 month follow-up visit
Title
Swallow biomechanics
Description
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Time Frame
Pre treatment visit
Title
Swallow biomechanics
Description
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Time Frame
1 month follow-up visit
Title
Swallow biomechanics
Description
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Time Frame
3 month follow-up visit
Title
Swallow biomechanics
Description
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: Time to laryngeal vestibule closure Time to upper esophageal sphincter opening Time to laryngeal vestibule opening
Time Frame
6 month follow-up visit
Title
Pharyngeal sensory evoked potential (pSEP)
Description
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time Frame
Pre treatment visit
Title
Pharyngeal sensory evoked potential (pSEP)
Description
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time Frame
1 month follow-up visit
Title
Pharyngeal sensory evoked potential (pSEP)
Description
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time Frame
3 month follow-up visit
Title
Pharyngeal sensory evoked potential (pSEP)
Description
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
Time Frame
6 month follow-up visit
Title
Pharyngeal motor evoked potentials (pMEP)
Description
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time Frame
Pre treatment visit
Title
Pharyngeal motor evoked potentials (pMEP)
Description
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time Frame
1 month follow-up visit
Title
Pharyngeal motor evoked potentials (pMEP)
Description
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time Frame
3 month follow-up visit
Title
Pharyngeal motor evoked potentials (pMEP)
Description
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Time Frame
6 month follow-up visit
Secondary Outcome Measure Information:
Title
Spontaneous swallowing frequency (SSF)
Description
SSF will be measured with surface neck electromyography and accelerometry for 10min to assess: the number of swallows per minute
Time Frame
Pre treatment visit and 1, 3 and 6 month follow-up visits
Title
Clinical outcomes: Hospital readmission rate
Description
Hospital readmissions (readmissions/100 persons-year)
Time Frame
Pre treatment visit and 1, 3 and 6 month follow-up visits
Title
Clinical outcomes: Prevalence of lower respiratory tract infections
Description
Lower respiratory tract infections (including pneumonia)
Time Frame
Pre treatment visit and 1, 3 and 6 month follow-up visits
Title
Clinical outcomes: Mortality
Description
Mortality rate
Time Frame
Pre treatment visit and 1, 3 and 6 month follow-up visits
Title
Responders rate
Description
Responders were defined as those patients who, after treatment, achieved safe swallow at a lower level of viscosity or, at the same viscosity level, improved at least one point in the penetration-aspiration scale.
Time Frame
6 month follow-up visit
Title
Treatment palatability: Taste
Description
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the taste using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time Frame
1, 3 and 6 month follow-up visits
Title
Treatment palatability: Texture
Description
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the texture using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time Frame
1, 3 and 6 month follow-up visits
Title
Treatment palatability: Future Adherence
Description
Facial scales on the palatability of the treatment will be performed from V2 to V4. Participants will be asked to respond to questions about the possible future adherence to the treatment if prescribed using the Face Likert scale: 1. Awful; 2. Not very good; 3. Okay; 4. Really good; 5. Fantastic.
Time Frame
1, 3 and 6 month follow-up visits
Title
Salivary neuropeptides
Description
Saliva samples will be collected in all study visits using the Salivette® technique, by putting a swab under the tongue for 5 min. The concentration of salivary neuropeptides substance P (SP) and calcitonin gene-related peptide (CGRP) will be determined by using 2 specific commercial Enzyme-Linked ImmunoSorbent Assay (ELISA) kits
Time Frame
1, 3 and 6 month follow-up visits
Title
Treatment safety
Description
Adverse events occurring during the study will be monitored according to the guideline of categories described by the world health organization
Time Frame
From the inclusion to the study until the end of their participation (6 month)
Title
Treatment compliance
Description
A sample of urine will be collected at each study visit and the concentration of riboflavin (part of the composition of the product from the 3 groups) will be extrapolated with fluorescence.
Time Frame
Pre treatment visit and 1, 3 and 6 month follow-up visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥70 years With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia Penetration-aspiration scale >1 in videofluoroscopy Able to follow the protocol and to give written informed consent. Exclusion Criteria: Life expectancy < 3m or palliative care Allergy to iodinated contrast or to the components of the treatment solutions Cancer or active infection Implanted electronic device Epilepsy Metal in the head Participation in another clinical trial (previous month).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Clavé, PhD
Phone
937417700
Ext
2284
Email
pere.clave@ciberehd.org
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD

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