The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus

NCT03193216 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro00065861
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barrett's over a shorter period of time.

Conditions

Barretts Esophagus With Dysplasia

Keywords

Barrett's; GERD; reflux; alginate solution; proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Successful Eradication

  To compare the percentage of patients who achieved complete endoscopic eradication of dysplastic Barrett's Esophagus(BE) and non-dysplastic BE with the combination of PPI and liquid alginate solution vs. those treated with PPI alone within eighteen months from the start of treatment.

  18 months

Secondary Outcomes (1)

• Number of Treatments (Mean)

  18 months

Study Arms (1)

Alginate group

EXPERIMENTAL

Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy

Drug: Alginates

Interventions

Alginates DRUG

Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.

Also known as: Gaviscon Advance

Alginate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age 18 (2) Biopsy-proven complicated BE (low/high grade grade dysplasia or IMC, confirmed by our institution's GI pathologist) As part of standard of care, all patients' biopsies will be confirmed with the institutions' GI pathologist and, either with outside biopsies or from biopsies completed at the primary institution.

You may not qualify if:

• \) Moderate to severe renal impairment, as defined by eGFR\< 60 for 2 consecutive readings (2) Lack of capacity for decision-making (3) Allergy to hydroxybenzoates (4) Patients with uncontrolled hypertension or decompensated heart failure (5) Pregnancy- patients of child-bearing potential will be tested. (6) Patients with elevated calcium or potassium on screening laboratory testing (labs completed within the last month)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Alginates

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Puja Elias, Associate Professor, PI for study
• Organization: Medical University of South Carolina

eliasps@musc.edu

8438764269

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot prospective cohort study at a single tertiary center who will be compared to historical controls.

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: August 25, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 8, 2023
• Results First Posted: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)