Trial · Interventional
CompletedPhase 1Registry dataGCC Agonist Signal in the Small Intestine
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 43 participants (actual)
- Sponsor
- University of Wisconsin, Madison · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 30 Nov 2022
- Primary completion
- 6 Feb 2026
- Completion
- 6 Feb 2026
- First posted
- 4 Nov 2021
- Last update posted
- 7 Apr 2026
- Conditions
- Barrett Esophagus · Gastroesophageal Reflux Disease · Malignant Digestive System Neoplasm
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.
Interventions
- BiopsyProcedure
- Biospecimen CollectionProcedure
- EsophagogastroduodenoscopyProcedure
- LinaclotideDrug
- PlecanatideDrug
Arms3
Experimental
Arm I (plecanatide, EGD)
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.
Experimental
Arm II (linaclotide, EGD)
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.
Active comparator
Arm III (EGD)
Patients undergo standard of care EGD with biopsy and luminal fluid collection.
Primary outcomes1
Outcomes the sponsor listed as primary.
Cyclic guanosine monophosphate (cGMP) levels
Time frame · Up to 2 years
Registry description
Will compare cGMP levels measured in normal-appearing duodenal mucosa biopsy specimens from participants receiving linaclotide or plecanatide to cGMP levels in specimens from participants receiving no active treatment. Will evaluate the difference between the control and each treated arm in cGMP levels using two-tailed two-sample Student t-tests. If necessary, a log transformation or Wilcoxon rank-sum will be used, as appropriate.
Secondary outcomes(2)
cGMP levels in luminal fluid
Time frame · Up to 2 years
Vasodilator-stimulated phosphoprotein (VASP) phosphorylation in normal appearing duodenal mucosa
Time frame · Up to 2 years
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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