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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)

Must not have

Active respiratory disease or recent (within 3 months) respiratory infections

Use of medications known to alter airway caliber (i.e. beta 2 agonists or anticholinergic agents)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24hours

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition or had a lung infection in the last 3 months.

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I am not taking medications that affect my airway, like asthma drugs.

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I have had surgery to remove all or part of my stomach.

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I have had esophageal cancer or surgery to remove part of my esophagus.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DeMeester Score

Secondary study objectives

Pulmonary Function Tests

Symptom Surveys and Questionnaires

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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