Comparative Efficacy and Safety of Polygel Dual and Other Antacids in the Treatment of Heartburn and Dyspepsia

Comparative Efficacy and Safety of Polygel Dual and Other Antacids in the Treatment of Heartburn and Dyspepsia: A Randomized Double-Blind Controlled Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202311905202771

Enrollment

240

Registered

2023-11-08

Start date

2023-11-02

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Heartburn and Dyspepsia

Interventions

Polygel Dual

Antacid 1

Antacid 2

Antacid 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients suffering from heartburn and/or regurgitation (more than 2 weekly episodes of heartburn) and indigestion. 2.Patients of both sexes who are 18 years and above. 3.Patients not on proton pump inhibitors (PPI) or H2-receptor antagonists in 7 days or any other antacids in the last 3 days 4.Patients willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Contraindications for the ingredients present in Polygel Dual and other study medications as per approved local prescribing information. 2.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study. 3.Pregnant or nursing women 4.Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) or steroids. 5.Patients with confirmed organic disease at upper GI endoscopy.

Design outcomes

Primary

Measure	Time frame
1.Change from baseline in Reflux Disease Questionnaire (RDQ) scores for GERD (heartburn and regurgitation) dimension and RDQ scores for dyspepsia dimension at day 2, day 7 and day 14	—

Secondary

Measure	Time frame
1.To assess the onset of relief of symptoms (Less than 5 min, 5- 10 min, 10-20 min, 20-30 min, more than 30 min) 2.To assess the duration of relief of symptoms (Less than 30 min, 30 min – 1 hr, 1-2 hr, 2-3 hr, 3-4 hr) 3.Global Assessment of patients and physicians’ satisfaction with the efficacy, rapidity of action and tolerability of the product (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 4.Palatability: Palatability of the product will also be assessed using the following scale (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 5.To assess adverse events during study duration	—

Measure

Time frame

1.To assess the onset of relief of symptoms (Less than 5 min, 5- 10 min, 10-20 min, 20-30 min, more than 30 min) 2.To assess the duration of relief of symptoms (Less than 30 min, 30 min – 1 hr, 1-2 hr, 2-3 hr, 3-4 hr) 3.Global Assessment of patients and physicians’ satisfaction with the efficacy, rapidity of action and tolerability of the product (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 4.Palatability: Palatability of the product will also be assessed using the following scale (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 5.To assess adverse events during study duration

—

Countries

Nigeria

Contacts

Public ContactSanjay Dubey

Clinical Trial Manager

Sanjay.Dubey@shalina.com+2349068644110

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026