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

Primary Purpose

Deglutition Disorders

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Piperine
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deglutition Disorders

Eligibility Criteria

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

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

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Piperine Dose 1

Piperine Dose 2

Arm Description

Piperine 1 mM

Piperine 150 microM

Outcomes

Primary Outcome Measures

Safety of swallow
Prevalence of penetrations at the laryngeal vestibule

Secondary Outcome Measures

Efficacy of swallow
Prevalence of oral and pharyngeal residue

Full Information

First Posted
June 27, 2011
Last Updated
February 27, 2015
Sponsor
Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT01383694
Brief Title
Effect Of Piperine In Patients With Oropharyngeal Dysphagia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piperine Dose 1
Arm Type
Experimental
Arm Description
Piperine 1 mM
Arm Title
Piperine Dose 2
Arm Type
Experimental
Arm Description
Piperine 150 microM
Intervention Type
Drug
Intervention Name(s)
Piperine
Primary Outcome Measure Information:
Title
Safety of swallow
Description
Prevalence of penetrations at the laryngeal vestibule
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Efficacy of swallow
Description
Prevalence of oral and pharyngeal residue
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://link.springer.com/article/10.1007%2Fs00535-013-0920-0
Description
Publication

Learn more about this trial

Effect Of Piperine In Patients With Oropharyngeal Dysphagia

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