All > Barretts Esophagus

Esophagogastroduodenoscopy for Acid Reflux

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acid Reflux+2 MoreEsophagogastroduodenoscopy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Acid Reflux
  • Abdominal Pain
  • Barrett's Esophagus

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Biopsy
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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Cellular response
Comparison pf cGMP and VASP phosphorylation between the plecanatide and linaclotide arms
Cyclic guanosine monophosphate (cGMP) levels
Vasodilator-stimulated phosphoprotein (VASP) phosphorylation in normal appearing duodenal mucosa
cGMP levels in luminal fluid

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Triapine
1
Biopsy
1
Iohexol

Trial Design

3 Treatment Groups

Arm III (EGD)
1 of 3
Arm II (linaclotide, EGD)
1 of 3
Arm I (plecanatide, EGD)
1 of 3

Active Control

Experimental Treatment

43 Total Participants · 3 Treatment Groups

Primary Treatment: Esophagogastroduodenoscopy · No Placebo Group · Phase < 1

Arm II (linaclotide, EGD)Experimental Group · 4 Interventions: Biospecimen Collection, Biopsy, Esophagogastroduodenoscopy, Linaclotide · Intervention Types: Procedure, Procedure, Procedure, Drug
Arm I (plecanatide, EGD)Experimental Group · 4 Interventions: Biospecimen Collection, Biopsy, Esophagogastroduodenoscopy, Plecanatide · Intervention Types: Procedure, Procedure, Procedure, Drug
Arm III (EGD)ActiveComparator Group · 3 Interventions: Biospecimen Collection, Biopsy, Esophagogastroduodenoscopy · Intervention Types: Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670
Biopsy
2014
Completed Phase 4
~1120
Esophagogastroduodenoscopy
2017
Completed Early Phase 1
~160
Linaclotide
FDA approved
Plecanatide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,098 Previous Clinical Trials
41,145,734 Total Patients Enrolled
David S WeinbergPrincipal InvestigatorFox Chase Cancer Center
2 Previous Clinical Trials
4,633 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand the nature and purpose of the study and the potential risks and benefits of participating in the study.
You are scheduled for a clinically indicated EGD.
You are willing to provide mandatory biospecimens as specified in the protocol.
You have a performance status of 0, 1, 2, or 3.
References

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