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Proton Pump Inhibitor

Anti-Reflux Therapy for Gastroesophageal Reflux Disease

Phase 1

Waitlist Available

Research Sponsored by James J. Peters Veterans Affairs Medical Center

Eligibility Criteria Checklist

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

Must have

Subjects with Tetraplegia (Level of SCI C4-8)

Subjects with High Paraplegia (Level of SCI T1-T7)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24hours

Awards & highlights

Study Summary

This trial will study the effects of anti-reflux therapy on respiratory symptoms in people with spinal cord injuries, to determine the underlying mechanisms of airway inflammation due to GERD.

Who is the study for?

This trial is for able-bodied individuals and those with spinal cord injuries (SCI) aged 18-75. It includes people with low paraplegia, tetraplegia, or high paraplegia who've had their injury for at least a year. Excluded are those with recent respiratory issues, chest blast injuries, esophageal cancer history, smokers or recent quitters, and users of certain airway-altering meds.Check my eligibility

What is being tested?

The study tests if anti-reflux therapy using Omeprazole affects respiratory function in SCI patients compared to able-bodied individuals. It involves tests like Esophageal Motility Study and Pulmonary Function Examination to understand GERD's impact on breathing.See study design

What are the potential side effects?

Omeprazole may cause side effects such as headache, stomach pain, nausea or vomiting, diarrhea or constipation. Rarely it can lead to more serious conditions like kidney problems or vitamin B12 deficiency over long-term use.

Eligibility Criteria

Inclusion Criteria

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

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I have paralysis in all my limbs due to a spinal cord injury between C4 and C8.

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My spinal cord injury is between the T1 and T7 levels.

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My spinal cord injury is at T8 level or lower, resulting in low paraplegia.

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I do not have a spinal cord injury.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

DeMeester Score

Secondary outcome measures

Pulmonary Function Tests

Symptom Surveys and Questionnaires

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: SCI GERDExperimental Treatment7 Interventions

For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD

Group II: Able-Bodied non-GERDActive Control6 Interventions

Able-bodied patients who are not diagnosed with GERD during screening will act as controls.

Group III: Able-bodied GERDActive Control6 Interventions

For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment.

Group IV: SCI non-GERDActive Control6 Interventions

SCI patients who are not diagnosed with GERD during screening will act as controls

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omeprazole

FDA approved

Exhaled Nitric Oxide

2010

N/A

~50

0 / 5Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,790 Total Patients Enrolled

Media Library

Omeprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02584751 — Phase 1

Gastroesophageal Reflux Disease Research Study Groups: Able-Bodied non-GERD, Able-bodied GERD, SCI non-GERD, SCI GERD

Gastroesophageal Reflux Disease Clinical Trial 2023: Omeprazole Highlights & Side Effects. Trial Name: NCT02584751 — Phase 1

Omeprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02584751 — Phase 1

Frequently Asked Questions

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

Are octogenarians being considered for participation in this clinical trial?

"To be considered for enrollment in this clinical trial, subjects must fall between 18 and 75 years of age."

Answered by AI

Could I be selected to participate in this trial?

"To qualify for this clinical trial, applicants must have a diagnosis of gastroesophageal reflux disease and age between 18 and 75. The total number of participants accepted is 110."

Answered by AI

Are there any open enrolment opportunities for this research study?

"Unfortunately, this clinical experiment is not currently seeking new participants. It was initially launched on the 1st of August 2016 and most recently edited on November 14th 2016. If you are searching for alternative studies, there are 67 trials recruiting patients with gastroesophageal reflux disease and 10 medical surveys that require extra personnel to complete pulmonary function examinations."

Answered by AI

Have any other studies assessed the efficacy of Pulmonary Function Examination?

"At present, 10 Pulmonary Function Examination clinical trials are ongoing. None of which have advanced to phase 3 yet. Most of these studies are situated in Portland, Oregon but the intervention is also being tested at 50 separate centres."

Answered by AI

What is the current size of the participant pool for this research endeavor?

"This medical trial is no longer accepting participants. Initially posted on August 1st 2016, the last update was made November 14th of that year. For those still searching for clinical studies related to gastroesophageal reflux disease, there are 67 trials currently looking for volunteers and 10 Pulmonary Function Examination investigations actively recruiting patients as well."

Answered by AI

What is typically the objective of a Pulmonary Function Examination?

"Pulmonary Function Examination is typically implemented to treat gastroesophageal reflux disease, yet it may also be employed for managing conditions such as heartburn, zollinger-ellison syndrome and healing."

Answered by AI

What risks should patients be made aware of before undergoing Pulmonary Function Examination?

"Based on the data we have, Pulmonary Function Examination is assessed to be a 1 as this trial only in Phase 1 with limited evidence of safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals

Miroslav Radulovic, M.D. 2016. "GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02584751.

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