Effect of Octreotide on Saliva

April 15, 2022 updated by: Duke University
The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults between the ages of 18-40 years old
  • Healthy volunteer who is willing to undergo research activities
  • Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Pregnant or nursing women
  • Children under the age of 18 or adults over 40
  • Complaint of oral symptoms (self-reported)
  • Medical condition affecting saliva (e.g. Sjogren's)
  • History of head/neck radiation
  • Medication that might affect saliva (e.g. Proton Pump Inhibitors)
  • Known allergy to Octreotide
  • Non-English speaking
  • Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Healthy Volunteer
Octreotide, 100 mcg (1 ml) s.c.
Drug: Octreotide 1 MG/ML
100 mcg (1 ml) of Octreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantify the change of saliva proteomes of subjects pre-octreotide treatment
Time Frame: Day 1 pre-treatment
Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source
Day 1 pre-treatment
To quantify the change of saliva proteomes of subjects post-octreotide treatment
Time Frame: Day 1 post-treatment
Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source
Day 1 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Walter Lee, MD, MHS, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 24, 2019

Primary Completion (ACTUAL)

February 26, 2020

Study Completion (ACTUAL)

February 26, 2020

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (ACTUAL)

April 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00100579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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