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.
NCT01648972 ↗	Gastrografin in Postoperative Ileus	Completed	University of Auckland, New Zealand	Phase 2/Phase 3	2012-09-01	After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital. The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.
NCT01790139 ↗	Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles	Completed	GE Healthcare	N/A	2013-02-01	To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.
NCT01790139 ↗	Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles	Completed	Asan Medical Center	N/A	2013-02-01	To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Clinical Trial Conditions for GASTROGRAFIN

Condition Name

Condition Name for GASTROGRAFIN
Intervention	Trials
Small Bowel Obstruction	2
Bowel Obstruction	1
Colon Cancer	1
Very Low Birth Weight Infant	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
France	1
New Zealand	1
China	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
Unknown status	1

Clinical Trial Sponsors for GASTROGRAFIN

Sponsor Name

Sponsor Name for GASTROGRAFIN
Sponsor	Trials
Lawson Health Research Institute	2
University Hospital, Rouen	1
Region Skane	1

Sponsor Type

Sponsor Type for GASTROGRAFIN
Sponsor	Trials
Other	13
Industry	1

Last updated: July 28, 2026

Gastrografin clinical trials update, market analysis, and forecast (2026)

Gastrografin (diatrizoate meglumine/diatrizoate sodium), an iodinated water-soluble contrast medium, remains a mature, off-patent product line with ongoing clinical-use evidence in radiology and related peri-procedural protocols. Demand tracks diagnostic imaging volumes, emergency medicine throughput, and procedural mix (GI contrast studies, fluoroscopy, CT adjunct use), with no near-term, patent-driven exclusivity inflection. Market growth is primarily volume-led and supply-chain dependent rather than innovation-led.

What is Gastrografin and what is it used for in clinical practice?

Gastrografin is used as an iodinated contrast agent, most commonly for gastrointestinal (GI) contrast studies such as suspected bowel obstruction, suspected perforation, and evaluation of the GI tract under fluoroscopy and radiography. It is also used in selected protocols as a radiographic contrast adjunct in emergency and peri-procedural settings where iodine contrast is needed.

Which indications drive use of iodinated GI contrast agents?

Demand drivers for this category include:

• Emergency department imaging for suspected obstruction/perforation
• Inpatient radiology volumes (surgeries, post-op complications)
• Fluoroscopy-based workflows
• Guideline-driven contrast selection for specific clinical pathways
• Competitive substitution within iodinated contrast portfolios (where formularies and procurement dominate)

How is Gastrografin typically administered and what does that mean for utilization?

Gastrografin is administered orally or via instillation depending on the study protocol, with use frequency linked to imaging ordering patterns and hospital diagnostic pathways.

What clinical trials involve Gastrografin and what is the latest direction of evidence?

Gastrografin is widely used as a comparator or active control in contrast-related studies, imaging workflow studies, and GI diagnostic algorithms rather than as a drug with a dedicated modern development program. The most relevant “clinical trials update” for a mature contrast agent is therefore typically:

• comparative imaging performance evaluations
• protocol optimization trials (dose, timing, route, and imaging modality workflows)
• safety and tolerability evaluations in special populations
• peri-procedural outcome studies tied to contrast use

What do recent trial types tend to show for iodinated contrast in GI imaging?

Across the contrast-agent literature, recent research patterns generally focus on:

• diagnostic accuracy in suspected obstruction/perforation pathways
• operational outcomes (time-to-imaging, workflow efficiency)
• safety monitoring parameters (iodine-related risk mitigation strategies)
• substitution effects when comparing iodinated contrast agents within the same therapeutic class

What endpoints matter most in trials where Gastrografin is used?

Typical primary or key endpoints include:

• diagnostic sensitivity/specificity and accuracy for obstruction/perforation
• positive predictive value in real-world ED settings
• adverse event rates, including hypersensitivity-type reactions and aspiration-related risks (where relevant)
• procedure completion rates
• readmission or surgical intervention decisions driven by imaging interpretation

When does Gastrografin lose exclusivity and how does that affect generic and substitution risk?

Gastrografin is a legacy iodinated contrast product and is not dependent on active small-molecule patent exclusivity to maintain market presence. Practical exclusivity risk in radiology contrast categories comes from:

• formulation and manufacturing process protections (where any exist for specific local products)
• local registrations and labeling
• supply availability and procurement contracts
• hospital formulary decisions and switching costs

How does off-patent status translate into market behavior for contrast media?

For mature contrast agents, generic substitution is usually faster and more procurement-led than innovation-led:

• hospitals select based on price, contract terms, and supply reliability
• interchangeability depends on local regulatory labeling and product equivalence
• tender cycles often override clinical nuance unless a specialty protocol demands a specific agent

What patents protect Gastrografin, and what is the patent estate strength?

A full, current patent estate map cannot be produced from the information available in this prompt alone. A high-stakes patent-lifecycle view requires a drug- and jurisdiction-specific patent list from authoritative databases (Orange Book or equivalent national registers) and litigation docket crosswalks. No such data is provided here.

What is the Orange Book status of Gastrografin?

A complete Orange Book status requires product listing identifiers and a queryable registry extract. No Orange Book listing data is included in the prompt.

How many generics or authorized alternatives compete with Gastrografin?

No competitor roster or market share dataset is provided in the prompt. A defensible count requires either:

• FDA Orange Book listing extraction for gastrografin active moieties and strengths, or
• tender/wholesale dataset, or
• company-level availability data per geography and pack size.

What generic entry risks exist for Gastrografin?

For off-patent contrast agents, the dominant “entry risk” is not regulatory patent-driven timing but operational and supply-chain barriers:

• batch manufacturing scale capability for iodinated solutions
• stability and quality control for high-iodine concentration products
• regulatory chemistry-manufacturing-controls readiness for local approvals
• logistics for cold-chain needs if any packaging or handling constraints apply (not specified in the prompt)

Which companies supply Gastrografin and competing iodinated contrast agents?

No company list is provided in the prompt. A credible competitive landscape requires manufacturer names tied to specific authorized presentations and jurisdictions.

What clinical, regulatory, and safety constraints limit use of iodinated GI contrast media like Gastrografin?

For iodinated contrast agents used in GI imaging, constraints typically include:

• iodine-related hypersensitivity risk management
• renal function considerations for iodinated products (though GI route exposure may be lower than IV in many settings)
• aspiration risk in patients with impaired swallow or high aspiration risk
• protocol-specific contraindications based on local labeling
• monitoring for adverse events in higher-risk populations

How does Gastrografin compare with alternative iodinated GI contrast agents?

A direct, evidence-based comparison requires specific competitor brands and their concentrations, dosing instructions, labeling, and clinical protocol equivalence. The prompt does not supply those comparator identities.

What is the market size for Gastrografin and how does it grow?

No market sizing inputs (units, revenue by geography, pack pricing, or procurement volumes) are included in the prompt. Without dataset support, market size and growth rates cannot be asserted without fabricating numbers.

Market projection for Gastrografin through 2030: what drives the forecast?

A practical projection framework for mature iodinated contrast products rests on:

• imaging volume growth (population, ED utilization, GI imaging utilization)
• procedural mix shift (fluoroscopy vs CT adjunct pathways)
• tender dynamics and substitution rates among equivalent iodinated contrast agents
• supply continuity and production capacity changes
• price pressure from generics and contract renegotiations

Forecast sensitivities that typically move contrast-media revenue

• Emergency imaging volume variation
• Hospital procurement cycles and switching among suppliers
• Price per vial/bottle adjustments and rebates
• Regulatory or labeling updates affecting eligible patient populations
• Supply disruptions and lot-level quality events

Key Takeaways

• Gastrografin is a mature iodinated GI contrast agent used primarily for radiology workflows linked to suspected obstruction/perforation and related GI diagnostics.
• Clinical evidence continues through protocol and workflow research, often using contrast agents as core components of diagnostic algorithms rather than as targets of drug innovation.
• Market dynamics are volume- and procurement-led, with off-patent behavior driving substitution and price competition.
• A quantified clinical trials update, patent estate strength, and numeric market forecast cannot be completed from the provided prompt inputs without introducing ungrounded claims.

FAQs

1. Is Gastrografin still used in emergency department imaging protocols for suspected bowel obstruction?
2. How do hospitals choose between iodinated GI contrast brands during radiology procurement tenders?
3. What safety monitoring is typically recommended for patients receiving iodinated contrast agents used for GI studies?
4. Do recent imaging workflows reduce the use of oral iodinated contrast compared with CT-only pathways?
5. What supply-chain factors most often affect availability and pricing for mature iodinated contrast media like Gastrografin?

References

1. (No sources were provided in the prompt.)