NCT01383694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

June 27, 2011

Last Update Submit

February 27, 2015

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

  • Safety of swallow

    Prevalence of penetrations at the laryngeal vestibule

    15 minutes

Secondary Outcomes (1)

  • Efficacy of swallow

    15 minutes

Study Arms (2)

Piperine Dose 1

EXPERIMENTAL

Piperine 1 mM

Drug: Piperine

Piperine Dose 2

EXPERIMENTAL

Piperine 150 microM

Drug: Piperine

Interventions

PiperineDRUG
Piperine Dose 1Piperine Dose 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Related Links

MeSH Terms

Conditions

Deglutition Disorders

Interventions

piperine

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

ES(1)