Acid Reflux Disease

About Acid Reflux Disease Clinical Trials (Click to Open)

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Acid Reflux Disease

General Purpose: 

Under normal conditions, a circular band of muscle at the base of the esophagus – known as the esophageal sphincter – prevents the backflow of food and liquid from the stomach into the esophagus. When this muscular valve malfunctions, stomach acid can flow backward into the esophagus, resulting in irritation of the lining of the esophagus.

This is known as acid reflux.  The symptoms associated with acid reflux can range from mildly irritating to downright painful, and include a burning sensation in the chest and/or throat (i.e., heartburn), sour taste in the mouth, chest pain, swallowing difficulty, dry cough, sore throat, hoarseness, regurgitation of food, and the sensation of a lump in the throat.

Acid reflux can occur as a result of overeating, consumption of fatty or spicy foods, smoking, obesity, and during pregnancy. Occasional acid reflux can be treated with the use of antacid medications that neutralize stomach acid, such as Maalox or Tums, as well as medications that decrease the amount of acid produced by the stomach (known as H-2-receptor blockers), including Pepcid AC and Zantac.

Research studies are currently evaluating the effectiveness of new antacid and H-2-receptor blockers for the treatment of acid reflux, as well as examining ways to prevent reflux from occurring in certain situations, such as following head and neck surgery. Scientists are also studying the ways in which acid reflux occurs on a microscopic level in the hopes of discovering new and better methods of treating it.

What Will Acid Reflux Disease Clinical Trials Be Like?

The types of tests and assessments used in acid reflux clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be used and incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Upper gastrointestinal (GI) endoscopy: a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the stomach and first part of the small intestine.
  • Ambulatory pH test: this procedure uses an acid-measuring device to determine the frequency and duration of stomach acid regurgitation into the esophagus. The monitor is often a thin, flexible tube that is threaded through the nose into the esophagus. It is hooked to a small computer worn around the waist, and takes approximately two days to perform.
  • Esophageal motility test: this test involves a similar tube as that which is used in an ambulatory pH test, however it measures the movement of and pressure within the esophagus.
  • You may be asked to take antacid medications, or refrain from taking antacid medications.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Acid Reflux Disease Clinical Trial Protocol:

Specific examples of clinical trials for acid reflux disease might include the following:

  • A study to evaluate the frequency with which acid reflux occurs in head and neck cancer patients who receive radiation therapy.
  • A randomized clinical trial to evaluate the effectiveness and safety of a new H-2-receptor blocker. In this trial, patients receiving the new drug would be compared to patients receiving a placebo.
  • A randomized clinical trial to determine if obese individuals with occasional acid reflux experience greater improvement in their symptoms when treated with a specific exercise and dietary intervention, compared to obese individuals who do not change their diet or exercise habits.
  • A study in which individuals with acid reflux provide a biopsy of their esophageal tissue for laboratory analysis.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the second clinical trial example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition. 

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of acid reflux (time since onset, specific diagnosis, etc.)
  • Your current medications (including aspirin), vitamins, and dietary supplements. 

Suggested Search Terms:

 “acid reflux prevention,” “acid reflux management,” “acid reflux treatment,” “acid reflux genetics,” “acid reflux diet,” “acid reflux exercise,” “acid reflux diabetes,” “acid reflux asthma,” “acid reflux children,” “acid reflux pediatric,” “acid reflux infants,” “acid reflux pregnancy,” and “acid reflux diagnosis,” and “acid reflux surgery.”

Also, using the term “heartburn” in conjunction with any of the keywords provided above may also yield additional trials of interest to you.

Current Search Term:

“Acid Reflux Disease”

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Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Condition:   Bile Reflux
Interventions:   Procedure: Omega Loop Gastric Bypass;   Device: Bilitec 2000™;   Device: V-Loc
Sponsor:   Medical University of Vienna
Not yet recruiting - verified March 2017

Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery

Condition:   Gastroesophageal Reflux
Intervention:   Other: Medical Files data extraction
Sponsor:   Pierre Wauthy
Not yet recruiting - verified March 2017

Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD

Condition:   Gastroesophageal Reflux Disease
Sponsor:   Affiliated Hospital to Academy of Military Medical Sciences
Recruiting - verified February 2017

Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease

Condition:   Gastroesophageal Reflux
Sponsor:   Mayo Clinic
Recruiting - verified February 2017

Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma

Conditions:   Asthma;   Gastroesophageal Reflux
Interventions:   Drug: commercially available lansoprazole;   Drug: matched placebo
Sponsors:   Jason Lang, M.D., M.P.H.;   Thrasher Research Fund;   Nemours Children's Clinic
Not yet recruiting - verified January 2017

Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication

Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: H pylori eradication;   Other: H pylori eradication timing
Sponsor:   National Taiwan University Hospital
Not yet recruiting - verified October 2016

Methoclopramide for Gastroesophageal Reflux in Premature Infants

Condition:   Gastroesophageal Reflux
Interventions:   Drug: Metoclopramide;   Drug: Placebo
Sponsors:   Nathalie Charpak;   Hospital Universitario San Ignacio;   Pontificia Universidad Javeriana
Not yet recruiting - verified September 2016

Lesogaberan in Chinese Patients With Refractory Reflux Symptoms

Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: Lesogaberan;   Drug: Placebo
Sponsors:   National Taiwan University Hospital;   Ministry of Science and Technology, Taiwan
Active, not recruiting - verified June 2016

Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

Conditions:   Non-erosive Reflux Disease;   Gastroesophageal Reflux
Interventions:   Drug: Proton Pump Inhibitor (PPI) Therapy;   Drug: Sucralfate
Sponsor:   Ochsner Health System
Recruiting - verified July 2016

Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease

Condition:   Gastroesophageal Reflux Disease
Interventions:   Other: Head of bed elevation;   Other: Standard treatment
Sponsor:   Universidad Nacional de Colombia
Recruiting - verified October 2016

Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants

Condition:   Gastroesophageal Reflux
Intervention:   Other: Tube feeding
Sponsors:   Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;   Ospedale dei Bambini "V. Buzzi", Milano
Enrolling by invitation - verified April 2017

Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).

Condition:   Gastro-oesophageal Reflux
Intervention:   Other: sitting position
Sponsor:   Vrije Universiteit Brussel
Recruiting - verified November 2016

Should I Continue Taking My Acid Reflux Medication? Development and Pilot Testing of a Patient Decision Aid

Conditions:   Proton Pump Inhibitors;   Gastroesophageal Reflux Disease
Intervention:   Other: Decision aid
Sponsor:   University of Ottawa
Completed - verified May 2017

Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Condition:   Laryngopharyngeal Reflux Disease
Interventions:   Drug: Motilitone;   Drug: Pantoprazole;   Drug: Placebo
Sponsor:   Samsung Medical Center
Recruiting - verified May 2016

The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

Condition:   GERD Gastroesophageal Reflux Disease
Interventions:   Drug: Omeprazole;   Device: LINX Reflux Management System
Sponsor:   Torax Medical Incorporated
Active, not recruiting - verified March 2017

The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study

Condition:   Gastroesophageal Reflux Disease
Intervention:   Device: TENS
Sponsor:   Rabin Medical Center
Recruiting - verified October 2016

Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

Condition:   Reflux Esophagitis
Sponsor:   AstraZeneca
Completed - verified March 2017

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: Dexlansoprazole 30 mg;   Drug: Dexlansoprazole 60 mg
Sponsor:   Takeda
Completed - verified July 2016

Sleep Position May Reduce Acid Reflux Symptoms at Night

Condition:   Extra-esophageal Reflux
Intervention:   Other: MedclineTM Sleep Assist Pillow
Sponsors:   Vanderbilt University Medical Center;   Amenity Health, Inc.
Terminated - verified April 2017

A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: E3810;   Drug: E3810;   Drug: E3810;   Drug: E3810
Sponsor:   Eisai Co., Ltd.
Completed - verified September 2016

Stretta In Reflux Uncontrolled by IPP

Condition:   Gastroesophageal Reflux Disease
Interventions:   Other: Stretta procedure;   Other: Sham procedure
Sponsor:   Nantes University Hospital
Recruiting - verified October 2016

Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study

Condition:   Non-erosive Reflux Disease
Interventions:   Drug: Esomeprazole;   Drug: Placebo
Sponsors:   Midwest Biomedical Research Foundation;   Kansas City Veteran Affairs Medical Center
Recruiting - verified September 2016

Prospective Pediatric Vesicoureteral Reflux Surgery Database

Condition:   Vesicoureteral Reflux
Sponsor:   Connecticut Children's Medical Center
Completed - verified January 2017

Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

Condition:   Laryngopharyngeal Reflux
Intervention:   Drug: Prevacid
Sponsor:   University of California, Davis
Completed - verified March 2009

Patient Education in Gastroesophageal Reflux Disease

Condition:   Gastroesophageal Reflux Disease
Intervention:   Behavioral: Patient education
Sponsors:   Norwegian University of Science and Technology;   Norwegian Foundation for Health and Rehabilitation
Completed - verified January 2017

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