A multicenter prospective randomized controlled trial: Comparison generic alginate Vs original alginate for symptoms controlled in the non-proton pump inhibitors responder GERD

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230119007

Enrollment

162

Registered

2023-01-19

Start date

2023-02-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

In patients with gastroesophageal reflux disease, despite taking proton pump inhibitors But only 25.7% of symptoms could be controlled in 7 days and only 35.9% of GERD patients were found to have no heartburn symptoms over 28 days. Patients with GERD are chronic and affect their quality of life worse compared to normal people. which often affects sleep decreased vitality more pain in the body impaired sexual feelings and more anxiety. GERD

Interventions

Previous standard-dose proton pump inhibitor plus generic alginate (ONE GERD) 1 pack 4 times per day until 28 days,Previous standard-dose proton pump inhibitor plus original alginate (Gaviscon dual s

Active Comparator Drug,Placebo Comparator Drug

Generic alginate,Original alginate

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Thai patients aged 18 years and older with a diagnosis of gastroesophageal reflux disease were treated with standard-dose proton pump inhibitors for at least 4 weeks but did not respond to treatment. The criteria for GERD diagnosis are: Typical symptoms of GERD include heartburn and belching at least twice a week. with symptoms continually for 1 month. or with a score greater than or equal to 8 using a standardized questionnaire to help diagnose GERD. (Gastroesophageal Reflux Disease Questionaire (GerdQ)). If the patient has warning symptoms (Alarm symptoms), they must do EGD before.

Exclusion criteria

Exclusion criteria: Psychiatric problems, Currently using prokinetic or H2 blocker or PCAB or alginate drug, Antiplatelet or NSAIDs using, Pregnancy, Previous surgery of esophagus, Alginate allergy, The patient in question is unable to listen or answer.

Design outcomes

Primary

Measure	Time frame
Number of response patients Day 7 and Day 28 Different of number of response patient	—

Secondary

Measure	Time frame
Symptom free days Day 28 Proportion,Adverse effect Day 28 Proportion	—

Countries

Thailand

Contacts

Public ContactKawin Tangvoraphonkchai

Srinagarind Hospital Khonkaen University

kawin_tang@hotmail.com0817082108

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026