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OpenTrials
Completed

NCT Number: NCT01383694

Effect Of Piperine In Patients With Oropharyngeal Dysphagia

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.

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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piperine

Drug

Primary outcomes

  1. Safety of swallow

    Time frame: 15 minutes

    Prevalence of penetrations at the laryngeal vestibule

Secondary outcomes

  1. Efficacy of swallow

    Time frame: 15 minutes

    Prevalence of oral and pharyngeal residue

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Official study title

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

Acronym: FIS 2009_2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2011
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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