CLINICAL TRIALS PROFILE FOR SUCRALFATE

All Clinical Trials for sucralfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00708149 ↗	Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial	Completed	Far Eastern Memorial Hospital	Phase 4	2009-06-01	The purpose of this study is to determine whether lansoprazole administered nasogastrically is effective for stress ulcer prophylaxis in respiratory intensive care unit.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Bausch Health Americas, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Yvonne Romero	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00633035 ↗	Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit	Completed	Far Eastern Memorial Hospital	Phase 4	2007-09-01	Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the tablets are soluble for the use of tube feeding. Our previous study showed that there was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence of nosocomial pneumonia was also similar. We will enroll those patients that have received intracranial surgery and admitted to neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
NCT00702871 ↗	A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia	Completed	Maulana Azad Medical College	Phase 4	2005-03-01	Objective of this study was to determine incidence, risk factors, etiological micro-organisms and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on occurrence of VAP. Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility pattern. Patients were divided into 2 groups on random basis. The first group was given ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter, difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate) and on occurrence of VAP in both the groups was compared. Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in developing countries like India. This data is crucial for providing information for deciding future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric colonization by pathogenic organism and increase incidence of Ventilator associated pneumonia; patients were divided into two groups on random basis, as described above.

Clinical Trial Conditions for sucralfate

Condition Name

Condition Name for sucralfate
Intervention	Trials
Dyspepsia	3
Mucositis Oral	1
Ulcer	1
Active Peptic Ulcer Disease/GI Bleeding	1

Condition MeSH

Condition MeSH for sucralfate
Intervention	Trials
Ulcer	4
Hemorrhage	3
Gastroesophageal Reflux	3
Dyspepsia	3

Clinical Trial Locations for sucralfate

Trials by Country

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−

Trials by Country for sucralfate
Location	Trials
United States	10
China	7
Taiwan	6
Brazil	2
United Kingdom	2

Trials by US State

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−

Trials by US State for sucralfate
Location	Trials
New York	2
Louisiana	2
Minnesota	2
New Jersey	1
Texas	1

Clinical Trial Progress for sucralfate

Clinical Trial Phase

Clinical Trial Phase for sucralfate
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for sucralfate
Clinical Trial Phase	Trials
Completed	14
Recruiting	5
Unknown status	2

Clinical Trial Sponsors for sucralfate

Sponsor Name

Sponsor Name for sucralfate
Sponsor	Trials
Far Eastern Memorial Hospital	3
National Cheng-Kung University Hospital	2
National Institute for Health Research, United Kingdom	2

Sponsor Type

Sponsor Type for sucralfate
Sponsor	Trials
Other	36
Industry	3

Sucralfate: Clinical Trials, Market Analysis, and Projections

Introduction to Sucralfate

Sucralfate is a unique anti-ulcer drug that has been widely used for treating various gastrointestinal conditions. It is a basic aluminum salt of sucrose octa-sulfate, known for its protective coating properties that shield the gastric mucosa from damage caused by pepsin, pectic acid, and bile salts[4].

Clinical Trials Update

Radiation Esophagitis Trial

One of the ongoing clinical trials involves testing sucralfate to prevent or reduce symptoms of radiation esophagitis in patients undergoing thoracic irradiation. This trial is significant because radiation esophagitis is a painful and common side effect of radiation therapy, particularly for those receiving chest radiation.

• Eligibility Criteria: The trial includes adults over 18 years old who are at high risk of developing esophagitis due to their radiation treatment. However, it excludes patients with feeding tubes, current opioid use, known issues with taking sucralfate, or a history of opioid addiction[1].
• Treatment Groups: The trial has multiple groups, including those receiving sucralfate in either oral suspension or tablet form, and those receiving usual care, which may include standard supportive care with opioids[1].
• Outcomes: Researchers will monitor symptom differences and weight loss among participants over a period that includes screening, treatment, and a two-year follow-up[1].

Efficacy in Duodenal Ulcers

Historically, sucralfate has been proven effective in treating duodenal ulcers. A multicenter, double-blind, placebo-controlled study showed that 91.7% of patients treated with sucralfate had complete healing of their duodenal ulcers after four weeks, compared to 58.1% in the placebo group[3].

Other Clinical Uses

Sucralfate is also used off-label for conditions such as chemotherapy-induced mucositis and radiation proctitis. For chemotherapy-induced mucositis, high-potency sucralfate has been shown to accelerate the activation of growth factors, aiding in the treatment of mucositis in the oropharynx and alimentary tract[4]. For radiation proctitis, sucralfate paste enemas have demonstrated clinical improvement in treating hemorrhagic radiation proctitis[4].

Market Analysis

Global Market Size and Forecast

The global market for sucralfate was estimated to be worth US$ 257.7 million in 2023 and is forecasted to reach US$ 300.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of 1.8% during the forecast period from 2024 to 2030[2].

U.S. Market Trends and Projections

In the U.S., the sucralfate market is expected to witness significant growth from 2024 to 2031. Key drivers include increasing demand for sucralfate products, an expanding customer base, and technological advancements.

• Market Segmentation: The U.S. sucralfate market is segmented by formulation (tablets and liquid suspension), indication (gastric ulcers, duodenal ulcers, GERD, and others), distribution channel (hospital pharmacy, retail pharmacy, and online pharmacy), and by state[5].
• Major Players: Key players in the U.S. sucralfate market include Teva Pharmaceutical Industries Ltd., Allergan plc, Vertice Pharma LLC, and Pharmaceutical Associates Inc.[5].

Competitive Landscape

The competitive landscape of the sucralfate market is characterized by a few major players. These companies are focusing on expanding their product lines, improving formulations, and enhancing distribution channels to capture a larger market share. The report by Coherent Market Insights provides a detailed analysis of the competitive aspects, including agreements, new product launches, and acquisitions[5].

Market Growth Factors and Trends

Increasing Demand

The increasing demand for sucralfate is driven by its efficacy in treating various gastrointestinal conditions. The drug's ability to form a protective coating on the mucosa makes it a preferred choice for conditions like duodenal ulcers and GERD[5].

Technological Advancements

Technological advancements in drug formulation and delivery systems are also contributing to the growth of the sucralfate market. For instance, the development of liquid suspensions and improved tablet formulations has enhanced patient compliance and treatment outcomes[5].

Expanding Customer Base

The expanding customer base, particularly in regions with growing healthcare infrastructure, is another factor driving the market growth. As more patients gain access to healthcare services, the demand for effective treatments like sucralfate is expected to increase[5].

Challenges and Constraints

Side Effects

While sucralfate is generally well-tolerated, it can cause side effects such as constipation, dry mouth, upset stomach, rash, or itching. These side effects, although typically mild, can affect patient compliance and overall market growth[1].

Regulatory Environment

The regulatory environment can also pose challenges. Changes in regulatory policies or the introduction of new drugs could impact the market dynamics of sucralfate. However, given its established efficacy and safety profile, sucralfate is likely to remain a significant player in the gastrointestinal treatment market[5].

Key Takeaways

• Clinical Efficacy: Sucralfate has been proven effective in treating duodenal ulcers and is being tested for its potential in preventing radiation esophagitis.
• Market Growth: The global sucralfate market is projected to grow from US$ 257.7 million in 2023 to US$ 300.2 million by 2030.
• U.S. Market Trends: The U.S. sucralfate market is driven by increasing demand, technological advancements, and an expanding customer base.
• Competitive Landscape: Major players like Teva Pharmaceutical Industries Ltd. and Allergan plc are key competitors in the U.S. sucralfate market.

FAQs

What is sucralfate used for?

Sucralfate is used to treat various gastrointestinal conditions, including duodenal ulcers, gastric ulcers, GERD, and off-label for conditions like chemotherapy-induced mucositis and radiation proctitis[4].

What are the potential side effects of sucralfate?

Potential side effects of sucralfate include constipation, dry mouth, upset stomach, rash, or itching[1].

How does sucralfate work?

Sucralfate works by forming a protective coating on the gastric mucosa, shielding it from damage caused by pepsin, pectic acid, and bile salts[4].

What is the current market size of sucralfate?

The global market for sucralfate was estimated to be worth US$ 257.7 million in 2023[2].

Who are the major players in the U.S. sucralfate market?

Major players in the U.S. sucralfate market include Teva Pharmaceutical Industries Ltd., Allergan plc, Vertice Pharma LLC, and Pharmaceutical Associates Inc.[5].

Sources

1. WithPower: "Sucralfate for Esophagitis - Clinical Trials"
2. Valuates Reports: "Sucralfate - Market, Report Size, Worth, Revenue, Growth, Industry"
3. PubMed: "Efficacy of sucralfate for duodenal ulcers: a multicenter, double-blind"
4. NCBI Bookshelf: "Sucralfate - StatPearls"
5. OpenPR: "U.S. Sucralfate Market Set to Witness Significant Growth"