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NCT01383694 Clinical Trial

Effect Of Piperine In Patients With Oropharyngeal Dysphagia

Deglutition Disorders Clinical Trial

— FIS 2009_2  

Official title:
Effect of Natural Agonists of TRPV1 in the Treatment of Functional Oropharyngeal Dysphagia in Neurological Diseases and the Elderly: Piperine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01383694
Other study ID # FIS 22/09
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 27, 2011
Last updated February 27, 2015
Start date June 2011
Est. completion date February 2012

Study information
Verified date February 2015
Source Hospital de Mataró
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing of dysphagic patients.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age>18

- History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases)

- Study explained and written subject information given

- Informed consent signed

Exclusion Criteria:

- Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media

- Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study

- Patients with a background of alcohol dependence or other drug dependence

- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Piperine

Locations
Country Name City State
Spain Hospital de Mataró Mataró Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of swallow Prevalence of penetrations at the laryngeal vestibule 15 minutes No
Secondary Efficacy of swallow Prevalence of oral and pharyngeal residue 15 minutes No
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