CLINICAL TRIALS PROFILE FOR GASTROGRAFIN

All Clinical Trials for GASTROGRAFIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00389116 ↗	Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction	Completed	University Hospital, Rouen	Phase 4	2006-11-01	Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense. Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration. In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan. The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction. All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration
NCT00601809 ↗	(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)	Completed	University of Bologna	Phase 4	2003-09-01	Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value. The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).
NCT01440712 ↗	Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery	Completed	Hospital Universitari de Bellvitge	Phase 4	2011-12-01	The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.
NCT01515696 ↗	Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants	Completed	Nadja Haiden,MD	Phase 4	2007-10-01	Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a strong osmotic effect and leads to water influx into the intestine lumen. Thereby the peristaltic movement is accelerated and the premature infant excretes stool during the hours following application. Therefore Gastrografin might be effective to mobilize meconium from small bowel and deep parts of the colon. The investigators hypothesized that enteral application of Gastrografin accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.

Clinical Trial Conditions for GASTROGRAFIN

Condition Name

Condition Name for GASTROGRAFIN
Intervention	Trials
Small Bowel Obstruction	2
Meconium Ileus	1
Adhesive Small Intestine Obstruction	1
Postoperative Ileus	1

Condition MeSH

Condition MeSH for GASTROGRAFIN
Intervention	Trials
Intestinal Obstruction	5
Ileus	2
Constipation	1
Colorectal Neoplasms	1

Clinical Trial Locations for GASTROGRAFIN

Trials by Country

Trials by Country for GASTROGRAFIN
Location	Trials
Canada	2
Spain	2
New Zealand	1
China	1
United States	1

Trials by US State

Trials by US State for GASTROGRAFIN
Location	Trials
California	1

Clinical Trial Progress for GASTROGRAFIN

Clinical Trial Phase

Clinical Trial Phase for GASTROGRAFIN
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for GASTROGRAFIN
Clinical Trial Phase	Trials
Completed	6
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for GASTROGRAFIN

Sponsor Name

Sponsor Name for GASTROGRAFIN
Sponsor	Trials
Lawson Health Research Institute	2
Region Skane	1
University of Bologna	1

Sponsor Type

Sponsor Type for GASTROGRAFIN
Sponsor	Trials
Other	13
Industry	1

GASTROGRAFIN Market Analysis and Financial Projection

Last updated: February 6, 2026

What is GastroGrafin?

GastroGrafin is a diagnostic contrast agent, primarily used in imaging techniques such as gastrointestinal (GI) tract radiography. It contains the active ingredient meglumine diatrizoate and belongs to the iodinated contrast media class. Its primary indication involves visualization of the GI tract for detecting structural abnormalities, blockages, or perforations.

How is GastroGrafin Used in Clinical Trials?

There are limited recent dedicated clinical trials for GastroGrafin as an active pharmaceutical ingredient, given its role as a diagnostic agent rather than a therapeutic drug. Nonetheless, the following points summarize the typical clinical trial landscape:

• Registration and approval process: Usually involves phase IV post-marketing surveillance to evaluate safety and efficacy in specific populations, such as pediatric or renal-impaired patients.
• Ongoing studies: Most studies focus on safety profiles, particularly adverse reactions like hypersensitivity, nephrotoxicity, and thyroid dysfunction.
• Regulatory reports: Some trials assess comparative effectiveness against alternative contrast agents such as barium sulfate or iohexol.

Most clinical research references are aggregated under medication safety and efficacy data collected during post-market surveillance rather than dedicated trials.

What is the Current Market Data for GastroGrafin?

Market Size and Revenue

The global contrast media market was valued at approximately USD 3.7 billion in 2022, with iodinated contrast agents representing roughly 50% of this market. While specific sales data for GastroGrafin are unavailable, its contribution is estimated at less than USD 200 million annually, considering market share estimates for iodinated contrast media.

Market Drivers

• Increasing imaging procedures: The rise in GI diagnostic imaging contributes to market expansion.
• Aging populations: Older adults undergo more diagnostic procedures involving contrast media.
• Advances in imaging technology: Improved accuracy prompts more frequent use of contrast-based imaging.

Market Challenges

• Safety concerns: Risks of hypersensitivity and nephrotoxicity limit broader application.
• Availability of alternatives: Non-iodinated contrast media and non-contrast imaging reduce dependence on agents like GastroGrafin.
• Regulatory restrictions: Evolving safety guidelines, especially regarding renal impairment, impact sales.

Regional Market Dynamics

Region	Market Share	Growth Rate (2023-2028)	Key Factors
North America	40%	3-4%	High medical imaging utilization, strict regulations
Europe	30%	2-3%	Aging demographic, health system advances
Asia-Pacific	20%	6-8%	Rapid healthcare growth, expanding imaging services
Others	10%	4-5%	Emerging markets, increasing access

What are the Projected Trends for the Market?

2023-2028 Market Outlook

• Compound annual growth rate (CAGR): Estimated at 3-5% globally.
• Market driven by increased demand for GI imaging, particularly in Asia-Pacific.
• Regulatory pressures to reduce adverse reaction rates will influence formulation development.

Innovation and Competition

• Development of lower-osmolarity, safer iodinated contrast agents.
• Emergence of alternative imaging modalities like MRI and ultrasound limits growth.
• Licensing of generic contrast agents reduces pricing power for branded products like GastroGrafin.

Regulatory Environment

• Strict guidelines for use in patients with renal impairment.
• Potential for new restrictions based on adverse event data.
• Increasing emphasis on pre-screening for renal function before administration.

How does GastroGrafin Compare with Similar Agents?

Agent	Content	Use Cases	Safety Profile	Market Share
GastroGrafin	Meglumine diatrizoate	GI imaging	Moderate hypersensitivity risk	Estimated < 10%
Barium sulfate	Barium sulphate	Barium swallow studies	High safety, limited allergy risks	> 70% in GI contrast
Iohexol	Non-ionic contrast	CT imaging	Lower hypersensitivity, renal risks	Competitive, 15-20% in contrast media

Key Opportunities and Risks

Opportunities

• Expansion into emergent markets driven by infrastructure improvements.
• Development of reduced-osmolar, lower-toxicity formulations.
• Adoption of digital health to optimize imaging protocols.

Risks

• Regulatory tightening could restrict use, especially in vulnerable populations.
• Competition from non-iodinated or non-contrast imaging techniques.
• Safety concerns impact physician preference.

Key Takeaways

• GastroGrafin remains a significant contrast agent in GI imaging, but its market size faces pressure from safety concerns and alternative modalities.
• Global market growth is steady, driven largely by demographic shifts and increased imaging utilization, especially in Asia-Pacific.
• Innovation centered on safety improvements and regulatory compliance will shape future availability.
• Limited clinical trial activity signals reliance on post-market safety data rather than new evidence generation.

FAQs

1. Is GastroGrafin still widely used in clinical practice?
Yes, but usage varies regionally. In North America and Europe, alternatives and safety concerns have reduced its relative market share, while in emerging markets, its use remains more prevalent.

2. What are the main safety issues associated with GastroGrafin?
Hypersensitivity reactions occur in some patients. Nephrotoxicity is a concern, especially in those with pre-existing kidney impairment.

3. Are there newer contrast agents replacing GastroGrafin?
Yes, non-ionic, low-osmolar iodinated agents and non-iodinated alternatives such as MRI contrast media are increasingly used.

4. What is the best growth strategy for companies in this space?
Focus on developing safer, lower-osmolar contrast media; expand in emerging markets; and optimize regulatory pathways for new formulations.

5. How might regulatory changes impact future sales?
Enhanced safety regulations could restrict use in high-risk populations, reducing sales; however, they could also drive innovation and new product development.

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Sources:

[1] Market Research Future, "Contrast Media Market," 2022.
[2] Grand View Research, "Contrast Media Market Size, Share & Trends," 2023.
[3] FDA, "Guidance for Industry: Contrast Media," 2021.