Clinical trial: Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients (NCT01872897)

Eligibility criteria:
Inclusion Criteria:

          -  meets the diagnostic criteria for GERD with a GERD history of frequent episodes of
             GERD-related symptoms during the last 2 months prior to study screening. The patient
             must also meet the following criteria:

               1. The only or main symptom is heartburn (burning feeling back of breast bone)
                  and/or acid reflux. Symptoms persists or have occurred repeatedly for more than 2
                  months;

               2. As assessed by the Investigator at screening by questioning of the patient, the
                  frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity
                  of heartburn in general is ≥ moderate within 3 weeks before screening

        Exclusion Criteria:

          -  Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥
             140g).

          -  Patients who have suffered cardiac chest pain within the last year.

          -  Patients who have suffered a recent, significant unexplained weight loss of more than
             6 Kg in the last 6 months.

          -  Female patients of childbearing potential who, for the duration of the study, are
             either unwilling or unable to take adequate contraceptive precautions or are unwilling
             to be sexually abstinent.

          -  Pregnancy or lactating mother.

          -  Patients with a history and/or symptom profile suggestive of the following: any other
             gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades
             C-D), Barrett's esophagus, acute peptic ulcer and/or ulcer complications,
             Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or
             gastric surgery, intestinal obstruction, current pernicious anaemia, indication for
             H-pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or
             hematemesis) within the last 3 months, and severe diseases of other major body
             systems.

          -  Patients who are observed at screening to have a hiatus hernia with a diameter which
             exceeds 3cm.

          -  Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for
             treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days
             prior to screening or throughout the study.

          -  Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2
             antagonists during the 5 days prior to screening or systemic glucocorticosteroids,
             non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can
             be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or
             quadruple therapy for eradication of H-pylori during the last 28 days.

          -  Patients taking or requiring to take macrolide antibiotics, such as erythromycin,
             azithromycin, from the day before screening.

          -  Patients with difficulty in swallowing.

          -  Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.

          -  Patients with severe constipation, or history of intestinal obstruction.

          -  In the opinion of the Investigator, patients with damaged heart or kidney function and
             patients who require a low sodium diet.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment