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Effect Of Piperine In Patients With Oropharyngeal Dysphagia (FIS 2009_2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383694
First Posted: June 28, 2011
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
  Purpose
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.

Condition Intervention Phase
Deglutition Disorders Drug: Piperine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Natural Agonists of TRPV1 in the Treatment of Functional Oropharyngeal Dysphagia in Neurological Diseases and the Elderly: Piperine

Resource links provided by NLM:


Further study details as provided by Pere Clave, Hospital de Mataró:

Primary Outcome Measures:
  • Safety of swallow [ Time Frame: 15 minutes ]
    Prevalence of penetrations at the laryngeal vestibule


Secondary Outcome Measures:
  • Efficacy of swallow [ Time Frame: 15 minutes ]
    Prevalence of oral and pharyngeal residue


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Piperine Dose 1
Piperine 1 mM
Drug: Piperine
Experimental: Piperine Dose 2
Piperine 150 microM
Drug: Piperine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383694


Locations
Spain
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Hospital de Mataró
  More Information

Additional Information:
Responsible Party: Pere Clave, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01383694     History of Changes
Other Study ID Numbers: FIS 22/09
First Submitted: June 27, 2011
First Posted: June 28, 2011
Last Update Posted: March 3, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Piperine
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action