Clinical trial: Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study (NCT01869491)

Eligibility criteria:
Inclusion Criteria:

          -  Current evidence of symptomatic GERD in accord with the Montreal definition

          -  Patients must have had troublesome heartburn and/or regurgitation (with or without
             dyspepsia symptoms) of at least mild or moderate intensity on at least five days
             during the week before the start of screening

        Exclusion Criteria:

          -  Patients who have a history of drug, solvent or alcohol abuse

          -  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 and/or discovered on endoscopy
             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 were observed on endoscopy 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, ulcermin 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 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 diseases and
             patients who require a low sodium diet.

          -  Any previous history of allergy or known intolerance to any of the IMP's
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