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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR GAVISCON


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gaviscon

Condition Name

Condition Name for Gaviscon
Intervention Trials
Gastroesophageal Reflux Disease 3
Gastroesophageal Reflux 1
Gastroesophageal Reflux Disease (GERD) 1
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Condition MeSH

Condition MeSH for Gaviscon
Intervention Trials
Gastroesophageal Reflux 5
Esophagitis, Peptic 2
Gastritis 1
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Clinical Trial Locations for Gaviscon

Trials by Country

Trials by Country for Gaviscon
Location Trials
Romania 2
Denmark 1
France 1
Italy 1
United Kingdom 1
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Trials by US State

Trials by US State for Gaviscon
Location Trials
South Carolina 1
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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
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Clinical Trial Status

Clinical Trial Status for Gaviscon
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Gaviscon

Sponsor Name

Sponsor Name for Gaviscon
Sponsor Trials
Sanofi 2
Nekkar Lab Srl 1
University Hospital Koge 1
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Sponsor Type

Sponsor Type for Gaviscon
Sponsor Trials
Other 8
Industry 3
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Gaviscon: Clinical Trials, Market Analysis, and Projections

Introduction to Gaviscon

Gaviscon is a well-known antacid medication used to treat symptoms of gastroesophageal reflux disease (GERD), including heartburn and regurgitation. It works by forming a barrier between the stomach and the esophagus, preventing stomach acid from flowing back up into the esophagus.

Clinical Trials: Efficacy of Gaviscon in GERD Treatment

Several clinical trials have been conducted to evaluate the efficacy of Gaviscon in managing GERD symptoms, particularly when used in conjunction with proton pump inhibitors (PPIs).

Randomized Clinical Trials

In two randomized, double-blind studies, patients taking standard-dose PPIs who experienced breakthrough symptoms were randomized to receive either Gaviscon or a placebo. The studies included an exploratory phase with 52 patients and a confirmatory phase with 262 patients.

  • Exploratory Study: This study showed significantly greater reductions in Heartburn Reflux Dyspepsia Questionnaire (HRDQ) scores for patients receiving Gaviscon compared to those receiving a placebo. Specifically, 75% of Gaviscon patients achieved a reduction of at least three "bad" days, compared to 36% of placebo patients[1][4].
  • Confirmatory Study: While symptomatic improvement was observed in 51% of patients receiving Gaviscon, there was no significant difference in response compared to the 48% of patients receiving a placebo. This suggests that the response to Gaviscon may vary depending on the functional origin of the symptoms[1][4].

Market Analysis of Gaviscon

Global Imports and Distribution

Gaviscon is widely imported and distributed globally, with significant activity observed from the United Kingdom. Between February 2023 and January 2024, the world imported 155 shipments of Gaviscon from the UK, supplied by 33 UK exporters to 36 global buyers. This period saw a 2% growth rate compared to the preceding year, although there was a notable year-on-year decline in January 2024[2].

Market Size and Growth Projections

The global antacids market, which includes Gaviscon, is expected to grow substantially in the coming years.

  • Current Market Size: The global antacids market was valued at USD 7.44 billion in 2024[5].
  • Growth Projections: The market is anticipated to reach USD 10.29 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 3.3% from 2024 to 2034. The North American market, which includes the U.S., is expected to grow at the fastest CAGR of 3.35% during this period[5].

Prevalence of GERD and Market Impact

The increasing prevalence of GERD is a significant driver of the antacids market, including Gaviscon.

  • GERD Prevalence: GERD is a chronic condition characterized by the regurgitation of stomach acid into the esophagus, leading to symptoms like heartburn. The global surge in GERD cases is attributed to lifestyle changes, dietary shifts, heightened stress levels, and rising obesity rates[5].
  • Market Demand: The escalating occurrence of GERD is expected to drive the demand for antacids like Gaviscon, contributing to the market's growth over the forecast period.

Emerging Therapies and Market Competition

The GERD market is evolving with the introduction of novel therapies, which could impact the market position of existing treatments like Gaviscon.

  • Novel Therapies: New treatments such as vonoprazan (approved by the FDA in November 2023), MHS-1031, and BLI5100 are expected to enter the market. These therapies offer improved efficacy and may address unmet needs in GERD treatment, such as dysmotility elements[3].
  • Market Competition: The introduction of these emerging therapies will likely increase competition in the GERD market. However, Gaviscon's established presence and efficacy in managing breakthrough symptoms will continue to make it a relevant treatment option.

Economic and Healthcare Implications

The economic and healthcare implications of GERD treatment are significant and influence the market dynamics.

  • Economic Burden: The cost associated with diagnostic tests, medications, surgeries, and potential complications of GERD can be substantial for individuals and healthcare systems. This economic burden underscores the need for effective and cost-efficient treatments like Gaviscon[3].
  • Healthcare Systems: The fragmented landscape of GERD treatments, including medications and surgical interventions, complicates marketing efforts and product positioning. However, Gaviscon's simplicity and effectiveness make it a preferred choice for many patients and healthcare providers.

Key Takeaways

  • Clinical Efficacy: Gaviscon has shown efficacy in reducing breakthrough GERD symptoms, particularly when used in conjunction with PPIs, although responses may vary.
  • Market Growth: The global antacids market, including Gaviscon, is projected to grow at a CAGR of 3.3% from 2024 to 2034.
  • GERD Prevalence: The increasing prevalence of GERD driven by lifestyle changes and other factors will continue to drive demand for antacids like Gaviscon.
  • Emerging Therapies: The introduction of novel GERD therapies will increase market competition but is unlikely to replace established treatments like Gaviscon entirely.
  • Economic and Healthcare Implications: Effective and cost-efficient treatments like Gaviscon are crucial given the significant economic burden of GERD.

FAQs

What is Gaviscon used for?

Gaviscon is used to treat symptoms of gastroesophageal reflux disease (GERD), including heartburn and regurgitation.

How does Gaviscon work?

Gaviscon works by forming a barrier between the stomach and the esophagus, preventing stomach acid from flowing back up into the esophagus.

What were the findings of the clinical trials on Gaviscon?

Clinical trials showed that Gaviscon reduced breakthrough GERD symptoms, although the response was not significantly different from placebo in the confirmatory study. The exploratory study indicated a greater reduction in HRDQ scores for Gaviscon patients compared to placebo patients[1][4].

What is the projected growth of the antacids market?

The global antacids market is expected to grow from USD 7.44 billion in 2024 to USD 10.29 billion by 2034, at a CAGR of 3.3%[5].

How does the increasing prevalence of GERD impact the market for Gaviscon?

The increasing prevalence of GERD, driven by lifestyle changes and other factors, is expected to drive the demand for antacids like Gaviscon, contributing to the market's growth over the forecast period[5].

What are some emerging therapies in the GERD market?

Emerging therapies include vonoprazan, MHS-1031, and BLI5100, which offer improved efficacy and may address unmet needs in GERD treatment[3].

Sources

  1. Randomised clinical trial: addition of alginate‐antacid (Gaviscon ... - Wiley Online Library
  2. Gaviscon Imports in World from United Kingdom - Volza.com
  3. Gastroesophageal Reflux Disease Market to Grow at a Substantial Growth Rate by 2032 - GlobeNewswire
  4. Randomised clinical trial: addition of alginate-antacid (Gaviscon ... - Research Profiles, University of Copenhagen
  5. Antacids Market Size To Hit USD 10.29 Billion By 2034 - Precedence Research
Last updated: 2025-01-07

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