HealthyPhase 1NCT05340192
Effect of Octreotide on Saliva
A Phase 1 study testing Octreotide 1 MG/ML in people with Healthy, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Octreotide 1 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 26 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Octreotide 1 MG/ML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide 1 MG/MLDrug
100 mcg (1 ml) of Octreotide
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Other | Octreotide, 100 mcg (1 ml) s.c. Receives: Drug: Octreotide 1 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 pre-treatment
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
Measured: Day 1 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start24 Sep 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Lee, MD, MHS, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340192
- Sponsor's protocol ID
- Pro00100579
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Octreotide on Saliva
- ClinicalTrials.gov ID
- NCT05340192
- Acronym / sponsor ID
- Pro00100579
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Other | Drug: Octreotide 1 MG/MLOctreotide, 100 mcg (1 ml) s.c. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide 1 MG/ML100 mcg (1 ml) of Octreotide | Drug | Healthy Volunteer |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Lee, MD, MHS principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Octreotide 1 MG/ML in people with Healthy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify the change of saliva proteomes of subjects pre-octreotide treatment (time frame: Day 1 pre-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.