CLINICAL TRIALS PROFILE FOR GAVISCON

All Clinical Trials for GAVISCON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01373970 ↗	The Clinical Significance of Acid Rebound in Functional Dyspepsia	Terminated	University Hospital Koge	Phase 4	2011-05-01	Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether this also applies for patients with dyspeptic symptoms but without true reflux disease (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult. This is a single centre, randomized, double-blinded, placebo-controlled cross over study. Study period is 12 weeks per study subject. Study subjects are referred to the study from General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the investigational centre. The study population consists of patients who seek their GP because of dyspepsia without alert signs, and whom the GP may consider starting on PPI. Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate. Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter Urease Test (HUT). Hp. positive subjects without ulcus are not excluded. Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint (Development of GERD) but will be included in the analysis regarding one of the secondary endpoints (Effect of PPI on Functional Dyspepsia). Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo. Escape medication in the form of Gaviscon can be used on demand. Internet based questionnaires are answered weekly. Questionnaires consist of the Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease (GERD). Compliance to protocol is assessed at hospital visits every fourth week. At the end of study endoscopy and pH monitoring are repeated.
NCT01373970 ↗	The Clinical Significance of Acid Rebound in Functional Dyspepsia	Terminated	Zealand University Hospital	Phase 4	2011-05-01	Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether this also applies for patients with dyspeptic symptoms but without true reflux disease (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult. This is a single centre, randomized, double-blinded, placebo-controlled cross over study. Study period is 12 weeks per study subject. Study subjects are referred to the study from General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the investigational centre. The study population consists of patients who seek their GP because of dyspepsia without alert signs, and whom the GP may consider starting on PPI. Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate. Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter Urease Test (HUT). Hp. positive subjects without ulcus are not excluded. Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint (Development of GERD) but will be included in the analysis regarding one of the secondary endpoints (Effect of PPI on Functional Dyspepsia). Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo. Escape medication in the form of Gaviscon can be used on demand. Internet based questionnaires are answered weekly. Questionnaires consist of the Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease (GERD). Compliance to protocol is assessed at hospital visits every fourth week. At the end of study endoscopy and pH monitoring are repeated.
NCT02783378 ↗	48 Hours Esophagal pH-monitoring With and Without Gaviscon	Completed	Universitair Ziekenhuis Brussel	N/A	2016-02-24	At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.
NCT03065816 ↗	Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects	Completed	Sanofi	Phase 1	2017-02-09	Primary Objective: Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects. Secondary Objective: Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in healthy adult subjects.
NCT03069963 ↗	PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects	Completed	Sanofi	Phase 1	2017-02-24	Primary Objective: Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects. Secondary Objective: Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
NCT03193216 ↗	The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus	Active, not recruiting	MUSC GI and research staff	Phase 2	2017-08-25	This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barrett's over a shorter period of time.

Clinical Trial Conditions for GAVISCON

Condition Name

Condition Name for GAVISCON
Intervention	Trials
Gastroesophageal Reflux Disease	3
Barretts Esophagus With Dysplasia	1
Functional Dyspepsia	1
Gastroesophageal Reflux	1

Condition MeSH

Condition MeSH for GAVISCON
Intervention	Trials
Gastroesophageal Reflux	5
Esophagitis, Peptic	2
Barrett Esophagus	1
Gastritis	1

Clinical Trial Locations for GAVISCON

Trials by Country

Trials by Country for GAVISCON
Location	Trials
Romania	2
Malaysia	1
Belgium	1
United States	1
Denmark	1

Trials by US State

Trials by US State for GAVISCON
Location	Trials
South Carolina	1

Clinical Trial Progress for GAVISCON

Clinical Trial Phase

Clinical Trial Phase for GAVISCON
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GAVISCON
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Terminated	1

Clinical Trial Sponsors for GAVISCON

Sponsor Name

Sponsor Name for GAVISCON
Sponsor	Trials
Sanofi	2
Medical University of South Carolina	1
Universiti Sains Malaysia	1

Sponsor Type

Sponsor Type for GAVISCON
Sponsor	Trials
Other	8
Industry	3

Last updated: July 24, 2026

Gaviscon Clinical Trials Update, Market Analysis, and Projection (Global Antacids/Alginate Reflux Portfolio)

Executive summary: Public “Gaviscon” clinical-trials and market data are fragmented because “Gaviscon” is a brand family spanning multiple actives (commonly sodium alginate with antacids such as sodium bicarbonate and/or calcium carbonate, depending on country and formulation) and multiple dosage forms. This analysis covers the drug class-and-brand economic profile rather than a single, uniquely defined molecular asset. Current publicly available evidence supports ongoing demand for alginate-based GERD and reflux control across pharmacies and OTC channels, with growth tied to population aging, reflux prevalence, and continued switch from Rx to self-care products. Patent and exclusivity analysis cannot be produced in a complete, accurate way without a specific Gaviscon composition and market.

Is Gaviscon still in clinical trials, and what phase are studies in?

Answer: There is no single, consolidated “Gaviscon” trials picture because the brand includes multiple formulations and dose forms. The clinical activity visible in public registries generally appears at the level of specific formulations, regional product variations, and comparator designs rather than one master asset.

What endpoints are used in Gaviscon-type reflux trials?

Commonly reported endpoints in alginate reflux studies include:

• Time to onset of symptom relief (heartburn/regurgitation)
• Sustained relief through defined time windows
• Proportion of patients “symptom-free” or with clinically meaningful symptom improvement
• Gastric reflux burden proxies (symptom diaries; in some studies, pH-impedance measures)
• Safety tolerability (GI adverse events; electrolyte-related events when bicarbonate/calcium are present)

What comparator patterns show up in reflux clinical studies?

• Standard-of-care H2 blockers and PPIs
• Other alginate antacids or raft-forming products
• Placebo plus rescue medication frameworks

Which study designs are most common?

• Randomized, controlled, short-cycle outpatient trials
• Non-inferiority or superiority symptom-relief studies
• Open-label observational tolerability studies in some regions

What does the latest clinical evidence say about Gaviscon efficacy and safety?

Answer: Across alginate-antacid portfolios, evidence typically supports rapid post-dose symptom control for heartburn and regurgitation, with safety dominated by antacid-class tolerability (constipation, diarrhea, gas/bloating) and, depending on formulation, exposure-relevant risks (electrolyte effects with sodium bicarbonate; calcium-related considerations for susceptible groups).

What safety signals matter for commercialization and labeling?

• Constipation risk in calcium carbonate-containing variants
• Sodium load considerations in patients with sodium-restricted diets
• Renal impairment precautions where labeling applies to antacid components

How do real-world and diary-based outcomes influence market uptake?

• OTC adoption is driven by perceived speed of relief and manageable side-effect profile
• Switch behavior depends more on ease-of-use and formulation preference than on long-horizon endpoints

What is the Gaviscon market size, and how fast is the reflux OTC segment growing?

Answer: The market is best modeled as the broader OTC reflux and heartburn segment plus alginate-based “raft-forming” variants. Gaviscon’s growth typically tracks:

• Rising GERD incidence and health-seeking behavior
• Aging demographics
• OTC self-medication penetration
• Competitive dynamics versus chewable antacids and alginate peers

Where does Gaviscon sell most?

Gaviscon is sold through:

• UK and broader Europe retail pharmacy channels (including supermarket and pharmacy chains where local rules allow)
• U.S. self-care channels with formulation-specific product variants
• Asia-Pacific in varying brand configurations and regulatory pathways

What drives pricing and SKU mix?

• Pack size and dosing frequency (therapeutic value in OTC)
• Formulation upgrades (liquid vs tablet; “Double Action” type variants; country-specific recipes)
• Retail promo cycles and channel rebates

How does Gaviscon compare with competitors in alginate GERD treatment?

Answer: Competitive pressure is split across three groups:

1. Alginate raft-forming products (direct functional substitutes)
2. Antacid tablets/liquids (faster symptom control but shorter duration for many patients)
3. Acid suppression (H2 blockers and PPIs) used upstream or when symptoms persist

Which attributes most affect share in OTC reflux?

• Onset of relief and “staying power” after meals and bedtime dosing
• Tolerability and “taste” or swallow/chew acceptability
• Availability in local pack formats and pharmacy stocking

When does Gaviscon lose exclusivity, and what patent estate risk exists for generics?

Answer: A complete and accurate exclusivity timeline cannot be produced for “Gaviscon” without specifying:

• The exact formulation (actives and ratios)
• The exact dosage form
• The exact country/market
• The relevant brand owner and listing identifiers

Gaviscon is a multi-formulation brand in which different SKUs can have different IP and regulatory histories. Any single “Gaviscon exclusivity date” would be incomplete and therefore not actionable.

What does this mean for generic entry risk?

For OTC GI symptom products, entry risk typically hinges on:

• Whether the formulation is still protected by composition-of-matter, formulation patents, or method-of-use claims
• Trade dress/brand trademark boundaries (marketing, not cure)
• Regulatory equivalency and bioequivalence requirements for liquids/tablets where applicable

A generics forecast that treats “Gaviscon” as one asset would misstate risk.

What is the Orange Book status of Gaviscon?

Answer: Orange Book status is not available in a complete way for “Gaviscon” as a brand family because Orange Book listings are substance-specific (active ingredient + dosage form + manufacturer, with application numbers). A reliable Orange Book answer requires mapping the exact Gaviscon SKU and active ingredients.

Are there any Paragraph IV challenges tied to Gaviscon?

Answer: Paragraph IV challenges are tied to ANDA filings for specific active ingredients and dosage forms. “Gaviscon” as a brand family spans multiple ingredient combinations that would need SKU-level mapping to identify any relevant ANDA litigation. Without that mapping, a correct Paragraph IV statement cannot be produced.

Does Gaviscon face biosimilar risk?

Answer: No. Gaviscon is not a biologic product; biosimilar frameworks do not apply.

What formulations of Gaviscon are most commercially important?

Answer: Commercial importance varies by country, but the largest revenue concentration is typically in:

• Liquid suspensions designed for post-meal and bedtime dosing
• Chewable or tablet formulations for portability and compliance
• Dual-action variants combining alginate with specific antacid components, depending on regulator approvals

How do formulation choices change clinical positioning?

• Liquid suspensions generally emphasize rapid dispersion and raft formation
• Chewables emphasize convenience and dosing adherence
• “Dual action” products emphasize both physical barrier effects and acid neutralization

What manufacturing or IP barriers could delay generic or private-label entry?

Answer: For alginate-antacid products, barriers tend to be formulation- and process-specific:

• Consistency of alginate properties and raft formation performance
• Stabilizer choices and shelf-life requirements
• Particle size and dispersion characteristics for liquids and tablets
• Regulatory documentation on equivalence where required

Brand-specific trade dress and regulatory history can also influence shelf outcomes even when legal product-level protection ends.

What licensing or settlement dynamics could affect Gaviscon competition?

Answer: Settlement dynamics can occur only if there is patent-litigation or regulatory exclusivity attached to a specific SKU. Without SKU-level mapping of active ingredients and manufacturing application records, no complete settlement assessment can be produced for “Gaviscon” as a brand family.

What is the regulatory status of Gaviscon across key markets?

Answer: In most markets, Gaviscon is positioned as an OTC GI product for heartburn and reflux symptom control. Regulatory pathways generally involve:

• Classification as OTC medicine or medical device or specific GI therapeutic product depending on country
• Ingredient-level compliance (antacid/alginate rules, labeling limits, sodium/calcium advisories)
• Post-marketing safety updates driven by pharmacovigilance

How many patents cover Gaviscon, and who owns them?

Answer: A complete count and ownership map cannot be produced for “Gaviscon” across all formulations and jurisdictions without specifying the exact SKU and its active ingredients and then searching by composition and related formulation claims.

Gaviscon vs. other GERD OTC options: where does it sit in the therapeutic hierarchy?

Answer: In OTC reflux care, alginate-antacid products are often positioned for:

• Breakthrough relief in mild-to-moderate GERD
• Bedtime and post-prandial symptom management
• Patients who prefer non-systemic therapy or cannot tolerate prescription therapies

Market projection for Gaviscon: base case, upside, and downside scenarios

Answer: Projections below are modeled as a category-driven OTC outlook for reflux symptom products with alginate-based differentiation. A precise “Gaviscon” revenue forecast cannot be computed without:

• SKU-specific unit and pricing data
• Geographic revenue split
• Current competitor set and channel share
• Currency baseline and time horizon

Base case (category growth with stable share)

• Growth follows overall OTC reflux category expansion
• Share is defended by formulation mix and retailer distribution
• Margin pressured by trade promotions and private label intensity

Upside case (accelerated alginate share and premiumization)

• Faster adoption of dual-action or improved convenience formats
• Stronger physician-to-OTC switching or guideline-aligned use
• Reduced competitive weakness due to supply stability

Downside case (private label and acid suppression substitution)

• Share shift to cheaper antacid/private label products
• Patients escalate to acid suppression when symptoms persist, reducing OTC alginate volume per user
• Regulatory or ingredient-label changes affecting marketing allowances

Key Takeaways

• “Gaviscon” is a brand family with multiple formulations, so clinical-trials and exclusivity analysis must be SKU-specific to be complete and accurate.
• Commercially, alginate-based reflux management sits in a stable OTC category supported by aging demographics and self-care behavior.
• Market growth is likely to track category expansion and formulation mix improvements, with margin sensitivity to promotions and private label substitution.
• Exclusivity, Orange Book status, and Paragraph IV risk cannot be stated accurately for “Gaviscon” without mapping the exact formulation, dosage form, and jurisdiction.

FAQs

1. Which exact Gaviscon formulation has the most published reflux efficacy data?
2. How does alginate-antacid efficacy compare with H2 blockers for bedtime heartburn?
3. What market data best predicts growth for OTC reflux brands: units, packs, or average selling price?
4. Do private-label alginate raft products compete mainly on price or on formulation claims?
5. What labeling elements most influence pharmacy stocking and OTC conversion for reflux products?

References

1. APA-formatted references cannot be produced because no specific clinical-trial registry entries, Orange Book listings, patent documents, or market data sources were cited in the provided prompt.