Clinical trial: Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study (NCT02623062)

Eligibility criteria:
Inclusion Criteria:

          -  Primary diagnosis: Current evidence of symptomatic GERD/NERD that comply with the
             Montreal definition of GERD/Nonerosive Esophageal Reflux Disease (NERD). GERD is a
             condition which develops when the reflux of stomach contents causes troublesome
             symptoms and/or complications. The concept of NERD is preserved in the typical reflux
             syndrome without esophageal injury, while reflux esophagitis falls under the category
             of esophageal syndromes with esophageal injury.

          -  GERD status: patients will be recruited by the Investigator from out-patient clinics,
             hospital database or those who respond to the advertising. Patients must have a GERD
             history of frequent episodes of GERD-related symptoms during the last 3 months, and
             must have had troublesome heartburn and/or regurgitation of at least moderate
             intensity on at least 4 days during the week before the start of screening.

          -  Patients must be sufficiently literate to be able to complete the RDQ unaided.

        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 (e.g. gastric or duodenal erosions and polyps larger
             than 0.5 cm), erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's
             esophagus, 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, hiatal
             hernias greater than 3 cm, known gastro-intestinal bleeding (hematochezia or
             hematemesis) within the last 3 months, and severe diseases of other major body
             systems.

          -  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 Proton Pump Inhibitors (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
             low dose aspirin given for cardioprotection) on more than 3 consecutive days during
             the last 28 days prior to screening or PPI-based triple or quadruple therapy for
             eradication of H-pylori during the last 28 days prior to screening and throughout the
             study.

          -  Patients who have taken any antacids within 24 hours before randomisation (Visit 2)
             and are unwilling or unable to withhold from taking them for the duration of the
             study.

          -  Patients taking mucous membrane protection drugs or motility stimulants within the 5
             days prior to screening and are unwilling or unable to withhold from taking them for
             the duration of the study.

          -  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 insufficient heart or kidney
             function and patients who require a low sodium diet.

          -  Patients with any co-existing condition which, in the opinion of the Investigator,
             would be likely to compromise patient safety or interfere with assessment of efficacy.

          -  Patients with any clinically significant abnormal laboratory values.

          -  Patients with severe/impaired renal function or insufficiency.

          -  Any previous history of allergy or known intolerance to any of the formulation
             constituents.

          -  Relevant clinically significant abnormalities in the physical examination, ECG and
             safety analysis.

          -  Previously randomised into the study.

          -  Employee at study site.

          -  Partner or first-degree relative (e.g. parents, siblings or children) of the
             Investigator.

          -  Participation in a clinical study in the previous 6 months.

          -  Unable in the opinion of the Investigator to comply fully with the study requirements.

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

          -  Patients who failed screening will not be allowed to re-enter the study
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