Clinical trial NCT01872897 (phase 3, status: completed)
Conditions: gastroesophageal reflux disease
ICD codes: K21.9, K21.00, K21.01
Drugs: sodium alginate double action tablets, placebo
SMILES: OC1C(O)C(OC2C(O)C(O)C(OP)OC2C(O)=O)OC(C1P)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.