MANTEINANCE TREATMENT IN NERD PATIENT. A COMPARATIVE RANDOMIZED OPEN STUDY BETWEEN ALGINATE AND MAGALDRATE. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002934-12-IT

Enrollment

224

Registered

2007-11-07

Start date

2007-06-12

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux MedDRA version: 9.1 Level: LLT Classification code 10038263 Term: Reflux oesophagitis

Interventions

Trade Name: GAVISCON*40CPR MAST Pharmaceutical Form: Chewable tablet INN or Proposed INN: ACIDO ALGINICO CAS Number: 9005-32-7 Concentration unit: mg milligram(s) Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 18-75 years Gastroesophageal reflux (GOR) Negative endoscopy damage of esophagus and stomach Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Concomitant PPI treatment Pregnancy Systemic disease like diabete liver injury or renal failure Zollinger ellison syndrome Treatement with NSAIDS and anticoagulants Positivity to helicobacter pylori

Design outcomes

Primary

Measure	Time frame
Main Objective: this study was aimed at comparing the efficacy and safety of alginate, which acts with a physical antireflux mechanism, and magaldrate anhydrous, chosen as a representative antacid because of its wide use over decades in the treatment of GOR in symptomatic patients.;Secondary Objective: None declared;Primary end point(s): The primary efficacy variable will be the total sum of scores for heartburn and acid regurgitation over the 4 weeks treatment period expressed as (a) the symptom intensity difference (SID), i.e., the difference obtained by subtracting the patient's sum of symptom score intensity (SSSI) at each time point from the patient's baseline sum of symptom score; (b) the sum of the symptom intensity difference (SSID), i.e., the baseline-adjusted sum of the SID scores over time, expressed as the area under the time-effect curve for the treatment period (4 weeks).	—

Measure

Time frame

Main Objective: this study was aimed at comparing the efficacy and safety of alginate, which acts with a physical antireflux mechanism, and magaldrate anhydrous, chosen as a representative antacid because of its wide use over decades in the treatment of GOR in symptomatic patients.;Secondary Objective: None declared;Primary end point(s): The primary efficacy variable will be the total sum of scores for heartburn and acid regurgitation over the 4 weeks treatment period expressed as (a) the symptom intensity difference (SID), i.e., the difference obtained by subtracting the patient's sum of symptom score intensity (SSSI) at each time point from the patient's baseline sum of symptom score; (b) the sum of the symptom intensity difference (SSID), i.e., the baseline-adjusted sum of the SID scores over time, expressed as the area under the time-effect curve for the treatment period (4 weeks).

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026