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Guanylyl Cyclase C Agonist

Esophagogastroduodenoscopy for Acid Reflux

Q: Are there any empty slots remaining for participants in this research trial?

Affirmative, the information accessible on clinicaltrials.gov confirms that this medical trial is engaging in active recruitment. Initially advertised on October 25th 2022 and last updated two days later, 43 prospective participants are sought from 2 study sites.

Q: Have any other investigations explored the effects of Esophagogastroduodenoscopy?

At the moment, 5 Esophagogastroduodenoscopy trials are in progress. 2 of those experiments have entered Phase 3 clinical trial stages. Philadelphia is home to most of these studies, but 147 other research sites can be found around the country.

Q: What is the overall enrollment for this medical study?

Affirmative. Clinicaltrials.gov data reveals that the trial is presently recruiting, having been posted on October 25th 2022 and last modified on October 27th 2022. 43 participants are being sought at 2 sites of study.

Phase 1

Recruiting

Led By David S Weinberg

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial looks at the effects of taking either plecanatide or linaclotide on a chemical in the small intestine, and how they compare to not taking either drug.

Who is the study for?

This trial is for adults over 18 who are not pregnant or breastfeeding, agree to use contraception, and have an ECOG performance status of <=1. They must be scheduled for an esophagogastroduodenoscopy (EGD), willing to provide biospecimens, and haven't used GCC agonists or investigational agents recently.Check my eligibility

What is being tested?

The study examines the effects of two FDA-approved constipation drugs, plecanatide or linaclotide, on a chemical in duodenal tissue from the small intestine compared to no drug treatment. Participants will undergo biospecimen collection including biopsy during EGD.See study design

What are the potential side effects?

While specific side effects aren't listed here, plecanatide and linaclotide can generally cause diarrhea, abdominal pain, swelling or bloating. Allergic reactions may occur if sensitive to similar compounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on long-term antiviral treatment for herpes.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My hepatitis B virus load is undetectable with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cyclic guanosine monophosphate (cGMP) levels

Secondary outcome measures

Vasodilator-stimulated phosphoprotein (VASP) phosphorylation in normal appearing duodenal mucosa

cGMP levels in luminal fluid

Other outcome measures

Cellular response

Comparison pf cGMP and VASP phosphorylation between the plecanatide and linaclotide arms

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (linaclotide, EGD)Experimental Treatment4 Interventions

Patients receive a single dose of linaclotide (145 mcg) PO 60-120 minutes prior to standard of care EGD with biopsy and luminal fluid collection.

Group II: Arm I (plecanatide, EGD)Experimental Treatment4 Interventions

Patients receive a single dose of plecanatide (3 mg) PO 60-120 minutes prior to standard of care EGD with biopsy and luminal fluid collection.

Group III: Arm III (EGD)Active Control3 Interventions

Patients undergo standard of care EGD with biopsy and luminal fluid collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1730

Esophagogastroduodenoscopy

2017

Completed Phase 3

~980

Linaclotide

2008

Completed Phase 4

~9200

Plecanatide

2016

Completed Phase 3

~10190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,838 Total Patients Enrolled

David S WeinbergPrincipal InvestigatorFox Chase Cancer Center

2 Previous Clinical Trials

4,633 Total Patients Enrolled

Media Library

Linaclotide (Guanylyl Cyclase C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05107219 — Phase 1

Acid Reflux Research Study Groups: Arm II (linaclotide, EGD), Arm I (plecanatide, EGD), Arm III (EGD)

Acid Reflux Clinical Trial 2023: Linaclotide Highlights & Side Effects. Trial Name: NCT05107219 — Phase 1

Linaclotide (Guanylyl Cyclase C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107219 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any empty slots remaining for participants in this research trial?

"Affirmative, the information accessible on clinicaltrials.gov confirms that this medical trial is engaging in active recruitment. Initially advertised on October 25th 2022 and last updated two days later, 43 prospective participants are sought from 2 study sites."

Answered by AI

Have any other investigations explored the effects of Esophagogastroduodenoscopy?

"At the moment, 5 Esophagogastroduodenoscopy trials are in progress. 2 of those experiments have entered Phase 3 clinical trial stages. Philadelphia is home to most of these studies, but 147 other research sites can be found around the country."

Answered by AI

What is the overall enrollment for this medical study?

"Affirmative. Clinicaltrials.gov data reveals that the trial is presently recruiting, having been posted on October 25th 2022 and last modified on October 27th 2022. 43 participants are being sought at 2 sites of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GCC Agonist Signal in the Small Intestine

2022. "GCC Agonist Signal in the Small Intestine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05107219.

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