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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT01383694
First received: June 27, 2011
Last updated: February 27, 2015
Last verified: February 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Hospital de Mataró:

Primary Outcome Measures:
  • Safety of swallow [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Prevalence of penetrations at the laryngeal vestibule


Secondary Outcome Measures:
  • Efficacy of swallow [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383694

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

Additional Information:
No publications provided

Responsible Party: Pere Clave, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01383694     History of Changes
Other Study ID Numbers: FIS 22/09
Study First Received: June 27, 2011
Last Updated: February 27, 2015
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on May 04, 2015