Effect of Octreotide on Saliva

Healthy Clinical Trial

Official title:

Effect of Octreotide on Saliva

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340192
• Other study ID #: Pro00100579
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Octreotide 1 MG/ML
100 mcg (1 ml) of Octreotide

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the change of saliva proteomes of subjects pre-octreotide 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
Primary	To quantify the change of saliva proteomes of subjects post-octreotide 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