Gastroesophageal Reflux Disease (GERD)

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Gastroesophageal Reflux Disease (GERD)

General Purpose:

Chronic acid reflux (i.e., that which occurs more than twice per week) leads to repeated irritation of the esophageal lining and can result in serious damage to the tissue. This chronic form of acid reflux is known as gastroesophageal reflux disease, or GERD.

Symptoms of GERD are similar to those of occasional acid reflux, and include 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. However, the chronic irritation associated with GERD can also lead to bleeding, breathing problems, and pre-cancerous lesions in the esophagus.

Obesity, pregnancy, overeating, and the consumption of fatty or spicy foods can lead to the development of occasional acid reflux, however, certain individuals are at an increased risk of developing GERD, including those with asthma, diabetes, and various connective tissue disorders such as scleroderma (chronic hardening of the skin).

Additionally, smoking increases the likelihood of having acid reflux progress to GERD, as does the presence of a hiatal hernia (a hernia that occurs when a portion of the stomach pushes through the diaphragm), chronic dry mouth, and gastroparesis (a condition characterized by delayed stomach emptying).

A variety of medications (both prescription and non-prescription) are available to treat the symptoms associated with GERD. These include 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).

Examples of H-2-receptor blockers include Pepcid AC and Zantac. A group of medications known as proton pump inhibitors block acid production and provide time for the damaged areas of the esophagus to heal. These medications include Prevacid and Prilosec.

Researchers are constantly working to identify new and better methods of treating GERD, as well as refining existing treatment regimens. Better methods of diagnosing GERD are also being developed and tested.

What Will Gastroesophageal Reflux Disease Clinical Trials Be Like?

The types of tests and assessments used in gastroesophageal reflux disease 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 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 Gastroesophageal Reflux Disease Clinical Trial Protocol:

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

  • A study to evaluate the effectiveness of a surgical treatment to strengthen and repair the esophageal sphincter in individuals with severe GERD.
  • A randomized clinical trial to determine if asthmatic individuals with GERD experience greater improvement in their symptoms when treated with a specific exercise and dietary intervention in addition to standard pharmaceutical therapy. In this study, patients would be randomly assigned to receive either the standard therapy plus the exercise/diet intervention, or standard therapy alone.
  • A randomized clinical trial to evaluate the effectiveness and safety of a new proton pump inhibitor in obese individuals who smoke. In this trial, patients receiving the new drug would be compared to patients receiving a placebo.

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 (such as the second example provided above).

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 third 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 gastroesophageal reflux disease (time since onset, specific diagnosis, etc.)
  • Your current medications (including aspirin), vitamins, and dietary supplements

Suggested Search Terms:

Once you are ready to begin your search for gastroesophageal reflux disease clinical trials, the following terms may be of use when combined with either “gastroesophageal reflux disease,” “GERD,” or “heartburn”:  “prevention,” “management,” “treatment,” “genetics,” “diet,” “exercise,” “diabetes,” “asthma,” “children,” “pediatric,” “pregnancy,” and “diagnosis,” and “surgery.”

Current Search Term:

“Gastroesophageal Reflux Disease (GERD)”

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Correlates of GERD Symptom Severity

Condition:   GERD
Sponsors:   Massachusetts General Hospital;   National Center for Complementary and Integrative Health (NCCIH)
Recruiting - verified May 2017

Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux

Condition:   GERD
Interventions:   Behavioral: Diaphragmatic Breathing;   Behavioral: Sham Comparator
Sponsor:   Mayo Clinic
Not yet recruiting - verified November 2016

STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD

Condition:   GERD
Interventions:   Device: Radio Frequency Ablation (RFA) (Stretta Procedure);   Procedure: Sham Procedure
Sponsor:   Asian Institute of Gastroenterology, India
Recruiting - verified October 2016

Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

Condition:   Gastroesophageal Reflux Disease
Interventions:   Drug: 10 mg ilaprazole;   Drug: 40mg esomeprazole
Sponsor:   Livzon Pharmaceutical Group Inc.
Completed - verified July 2016

HRIM vs Mucosal Impedance in GERD Participants

Condition:   Gastro-esophageal Reflux Disease (GERD)
Intervention:   Device: Mucosal Impedance
Sponsor:   Mayo Clinic
Enrolling by invitation - verified June 2016

Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD

Condition:   GERD
Intervention:   Device: Treatment with RefluxStop
Sponsor:   Implantica CE & Production Ltd
Not yet recruiting - verified April 2016

Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease

Condition:   GERD
Intervention:   Other: Controls & Cases
Sponsor:   Loren Laine
Completed - verified July 2016

Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients

Condition:   Gastro-esophageal Reflux Disease (GERD)
Interventions:   Drug: Compound Sodium Alginate Oral Suspension sachet;   Drug: Matched placebo
Sponsor:   Reckitt Benckiser Healthcare (UK) Limited
Recruiting - verified June 2016

Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.

Condition:   Patients With Typical Symptoms of GERD (GERD Q >= 8)
Sponsor:   AstraZeneca
Completed - verified March 2017

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

Condition:   Gastro Esophageal Reflux Disorder
Interventions:   Drug: Omeprazole;   Device: 24 Hour pH Monitor;   Procedure: Pulmonary Function Examination;   Procedure: Exhaled Nitric Oxide;   Procedure: Exhaled Breath Concentrate (EBC);   Procedure: Bernstein's Acid Clearance Test;   Procedure: Esophageal Motility
Sponsor:   James J. Peters Veterans Affairs Medical Center
Recruiting - verified November 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 Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department

Condition:   Gastroesophageal Reflux
Intervention:   Drug: Esomeprazole MUPS, 20 mg
Sponsor:   First Affiliated Hospital, Sun Yat-Sen University
Recruiting - verified January 2017

Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

Condition:   Gastroesophageal Reflux Disease
Intervention:   Other: Study
Sponsors:   Sudarshan Jadcherla;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);   Ohio State University
Recruiting - verified January 2017

Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD

Condition:   Gastro-esophageal Reflux Disease
Interventions:   Other: in vitro diagnostic test (Peptest);   Other: Questionnaire;   Other: Questionnaire
Sponsors:   MAAB (Shanghai) Medical Device Limited;   RD Biomed Ltd
Active, not recruiting - verified January 2017

Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI in Chinese Population: PASS-C

Condition:   Gastro-esophageal Reflux Disease
Sponsor:   Chinese University of Hong Kong
Recruiting - verified April 2017

A Study of Reflux Management With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

Conditions:   GERD;   Gastroesophageal Reflux Disease
Intervention:   Device: LINX device
Sponsor:   Torax Medical Incorporated
Recruiting - verified April 2017

Dietary Carbohydrate and GERD in Veterans

Conditions:   Gastroesophageal Reflux Disease;   Obesity
Intervention:   Other: Dietary Carbohydrate
Sponsor:   VA Office of Research and Development
Recruiting - verified February 2017

The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study

Condition:   Gastroesophageal Reflux
Interventions:   Drug: PPI therapy;   Procedure: Stool sample;   Procedure: Stool sample;   Procedure: Stool sample
Sponsor:   Medical University of Graz
Completed - verified February 2017

Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?

Conditions:   Gastroesophageal Reflux Disease;   GERD;   Acid Reflux;   Reflux
Intervention:   Drug: Quercetin
Sponsors:   University of North Carolina, Chapel Hill;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Completed - verified December 2016

Registry to Compare Two Surgical Treatments for GERD

Condition:   GastroEsophageal Reflux Disease
Sponsors:   American Gastroenterological Association;   EndoGastric Solutions
Terminated - verified April 2017

A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring

Condition:   GERD
Interventions:   Other: 24 pH monitoring;   Other: Esophageal Manometry:
Sponsor:   McMaster University
Suspended - verified April 2017

Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Condition:   Gastroesophageal Reflux Disease
Intervention:   Procedure: endoscopic full thickness plication
Sponsor:   Krankenhaus Barmherzige Schwestern Linz
Completed - verified February 2017

A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

Condition:   GERD
Interventions:   Device: Nissen fundoplication;   Drug: baclofen;   Drug: Desipramine
Sponsor:   VA Office of Research and Development
Completed - verified March 2017

A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease

Condition:   GERD
Interventions:   Drug: XP19986 CR;   Drug: Placebo for XP19986 CR
Sponsor:   Indivior Inc.
Completed - verified September 2016

An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

Condition:   Gastroesophageal Reflux
Interventions:   Drug: XP19986 SR3, 20 mg QD;   Drug: XP19986 SR3, 40 mg QD;   Drug: XP19986 SR3, 60 mg QD;   Drug: XP19986 SR3, 30 mg BID;   Drug: Placebo
Sponsor:   Indivior Inc.
Completed - verified September 2016

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