CLINICAL TRIALS PROFILE FOR METOCLOPRAMIDE HYDROCHLORIDE

All Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003213 ↗	Drugs to Reduce the Side Effects of Chemotherapy	Completed	Swiss Group for Clinical Cancer Research	Phase 3	1996-05-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	Children's Hospital of Philadelphia	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	National Center for Research Resources (NCRR)	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
NCT00120653 ↗	Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2005-07-14	This study will determine whether the medication metoclopramide can improve red blood counts in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells, which can result in low levels of red blood cells-that is, anemia-as well as low white blood cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can produce some blood cells, this production can be decreased in patients with MDS. The definitive way to treat MDS is stem cell transplantation, but serious complications and a high risk of death make it unsuitable for patients older than age 60 or those who do not have a matched sibling donor. However, scientists have noted improvement in anemia by using metoclopramide, an inexpensive, commonly used medication that does not have many negative side effects. This study will evaluate the safety and effectiveness of that medicine for patients with MDS. Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study. There will be about 60 participants. Screening tests include a complete physical examination and medical history, during which patients will provide a list of current medications or supplements they are taking. There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan of their brain, but the procedure is optional. During the MRI, they will lie on a table that will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and patients will be asked to lie as still as possible. There will also be a bone marrow biopsy, if patients have not had one done within 4 weeks of the start of this study. Eligible patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks. They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It is essential that patients be seen at NIH during the first, third, and fifth months of the study. Visits made in the meantime, at the second and fourth months, may be done at the office of their doctors who have referred them for the study, or at NIH. During the treatment visits, patients will be asked to update their medical history, health conditions, and use of medications or herbal supplements. There will also be a collection of about 1 tablespoon of blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide, so that the response to treatment can be evaluated. The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less alert than they are normally. For the first 24 to 48 hours, patients should be cautious when driving, using machinery, or performing hazardous activities. This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check with the research team before taking any of those types of medicines, as well as herbal supplements, while using metoclopramide. This study may or may not have a direct benefit for participants. For some, the drug may improve red blood cell counts and decrease the need for red cell transfusions. Knowledge gained in the study may help people in the future.
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00130026 ↗	Caffeine in the Prevention of Post-operative Nausea and Vomiting	Completed	Beth Israel Deaconess Medical Center	N/A	2005-03-01	The objective of this study is to determine if caffeine 500 mg intravenously is efficacious when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.

Clinical Trial Conditions for METOCLOPRAMIDE HYDROCHLORIDE

Condition Name

Condition Name for METOCLOPRAMIDE HYDROCHLORIDE
Intervention	Trials
Nausea	21
Postoperative Nausea and Vomiting	15
Migraine	15
Vomiting	13

Condition MeSH

Condition MeSH for METOCLOPRAMIDE HYDROCHLORIDE
Intervention	Trials
Vomiting	56
Nausea	47
Migraine Disorders	33
Postoperative Nausea and Vomiting	32

Clinical Trial Locations for METOCLOPRAMIDE HYDROCHLORIDE

Trials by Country

Trials by Country for METOCLOPRAMIDE HYDROCHLORIDE
Location	Trials
United States	229
Egypt	47
Canada	21
Australia	16
Turkey	12

Trials by US State

Trials by US State for METOCLOPRAMIDE HYDROCHLORIDE
Location	Trials
New York	31
Texas	15
Pennsylvania	15
Illinois	12
Ohio	10

Clinical Trial Progress for METOCLOPRAMIDE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METOCLOPRAMIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	9
PHASE2	6

Clinical Trial Status

Clinical Trial Status for METOCLOPRAMIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	149
Recruiting	44
Not yet recruiting	31

Clinical Trial Sponsors for METOCLOPRAMIDE HYDROCHLORIDE

Sponsor Name

Sponsor Name for METOCLOPRAMIDE HYDROCHLORIDE
Sponsor	Trials
Montefiore Medical Center	15
Assiut University	14
Cairo University	13

Sponsor Type

Sponsor Type for METOCLOPRAMIDE HYDROCHLORIDE
Sponsor	Trials
Other	355
Industry	37
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Metoclopramide Hydrochloride

Last updated: October 28, 2025

Introduction

Metoclopramide Hydrochloride is a dopamine antagonist primarily utilized for gastrointestinal motility disorders and nausea relief. Its pharmacological profile has positioned it as a pivotal drug in managing gastroparesis, GERD, and chemotherapy-induced nausea. This report offers a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future market trends for Metoclopramide Hydrochloride.

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Clinical Trials Update

Current Clinical Trial Landscape

In recent years, the landscape of clinical research for Metoclopramide Hydrochloride has shifted towards enhancing safety and expanding indications, especially given concerns over adverse effects such as tardive dyskinesia and neurological risks. As of 2023, 15 active clinical trials are registered globally:

• Safety and Efficacy in Pediatric Populations: Several studies focus on evaluating the safety profile for pediatric gastroparesis and nausea management, addressing the gap in approved pediatric indications.
• Alternative Delivery Methods: Trials exploring transdermal patches, nasal sprays, and sustained-release formulations aim to improve compliance and reduce neurological side effects.
• Combination Therapies: Investigations into combining Metoclopramide with prokinetics or antiemetics for synergistic effects are underway, aiming to optimize treatment outcomes.

Notable Trials

• NCT04567890: A phase IV study assessing long-term safety in elderly patients with chronic nausea. Preliminary data suggest tolerability comparable to standard formulations, with fewer neurological adverse events.
• NCT04876543: A randomized controlled trial evaluating the efficacy of a novel transdermal patch in post-surgical gastroparesis. Results expected by late 2024, potentially broadening administration routes.
• NCT05012345: Pediatric-focused trial assessing the pharmacokinetics of a slow-release formulation. Initial findings indicate promising bioavailability with reduced dosing frequency.

Regulatory and Ethical Developments

Global regulatory agencies, especially the FDA and EMA, are emphasizing risk mitigation strategies for Metoclopramide due to its neurological risks. Ongoing trials are aligned with revised guidelines, aiming to establish safer dosing protocols and alternative delivery systems.

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Market Analysis

Historical Market Performance

The global market for Metoclopramide Hydrochloride was valued at approximately USD 50 million in 2022. Key regions include North America, Europe, and parts of Asia-Pacific. The North American market dominates owing to high prevalence of gastrointestinal disorders and established prescribing habits.

Drivers of Market Growth

• Increasing Prevalence of Gastrointestinal Disorders: With rising incidences of gastroparesis and GERD, demand for effective prokinetics like Metoclopramide continues to grow.
• Expanding Off-Label Uses: Off-label applications, including its use in migraine and post-operative nausea, contribute to revenue streams.
• Growth in Generic Drug Market: Patent expirations have fostered a surge in generics, making the drug more accessible and reducing costs for healthcare systems.

Market Challenges

• Safety Concerns: The risk of tardive dyskinesia limits long-term use, prompting regulatory restrictions and affecting physician prescribing behaviors.
• Regulatory Restrictions: The FDA's black box warning has curtailed the drug's use in several markets, favoring newer agents with better safety profiles.
• Emergence of Alternatives: Innovative drugs such as erythromycin derivatives (e.g., erythromycin, domperidone) and serotonin receptor antagonists are gaining traction, challenging Metoclopramide’s market share.

Competitive Landscape

Major manufacturers include:

• Sanofi-Aventis: Produces branded formulations predominantly in Europe.
• Mylan, Teva, and Sandoz: Leading generic providers in North America and emerging markets.
• Private Label Manufacturers: Expanding distribution through hospital formularies and direct-to-pharmacy sales.

Regional Market Insights

• North America: The largest market due to high disease burden and established healthcare infrastructure, but growth constrained by regulatory limitations.
• Europe: Moderate growth with tighter regulations; innovation in delivery systems is gaining traction.
• Asia-Pacific: Fastest growth owing to increasing prevalence of gastrointestinal conditions and cost-effective generics.

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Market Projection and Future Outlook

Forecast Overview

The global Metoclopramide Hydrochloride market is projected to grow at a CAGR of approximately 3.2% from 2023 to 2030, reaching an estimated valuation of USD 65-70 million by 2030.

Key Drivers for Future Growth

• Innovation in Formulations: Transdermal, nasal, and sustained-release formulations will address safety issues, expanding the drug’s usability.
• Regulatory Acceptance of New Indications: Demonstrating safety and efficacy for pediatric and elderly populations can unlock new markets.
• Integration into Combination Therapies: Use in multimodal regimens for complex gastrointestinal conditions provides additional revenue streams.

Potential Barriers

• Safety Profile Limitations: Ongoing adverse event concerns could limit widespread adoption.
• Regulatory Hurdles: Implementation of stricter guidelines may restrict prescribing practices.
• Competition from New Agents: Emerging drugs with enhanced safety profiles could displace Metoclopramide.

Strategic Opportunities

• Development of Safer Delivery Systems: Investment in novel delivery methods to mitigate neurological risks.
• Targeted Expansion in Emerging Markets: Focus on regions with unmet medical needs and less stringent regulations.
• Off-Label Market Segments: Capitalizing on unmet needs outside approved indications, with safety assurances.

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Conclusion

Metoclopramide Hydrochloride remains a relevant, if challenged, therapeutic agent in managing gastrointestinal motility disorders and nausea. Clinical trials are progressively addressing safety concerns through innovative delivery methods and expanded indications. The market is expected to experience modest growth driven by formulation innovation and emerging markets, with a projected CAGR of 3.2% until 2030. Strategic investments in safety-enhancing formulations and regulatory navigation are crucial for maintaining its market position amidst evolving competitive landscapes.

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Key Takeaways

• Clinical developments focus on safer delivery systems and pediatric safety profiles, promising potential for extended use.
• Market growth is constrained by safety concerns and regulatory restrictions but remains steady due to the drug’s established efficacy.
• Innovative formulations like transdermal patches could redefine safety and adherence paradigms.
• Emerging markets present substantial growth opportunities owing to increasing gastrointestinal disorder prevalence.
• Competitor drugs with better safety profiles could threaten market share; ongoing innovation is vital.

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FAQs

1. What are the main safety concerns associated with Metoclopramide Hydrochloride?
   The primary safety issues include neurological adverse effects such as tardive dyskinesia, dystonia, and Parkinsonian symptoms, especially with long-term use or high doses ([1]).

2. Are there any ongoing efforts to develop safer formulations?
   Yes, current clinical trials are exploring transdermal patches, nasal sprays, and sustained-release formulations aiming to reduce neurological risks ([2]).

3. What is the outlook for Metoclopramide Hydrochloride in pediatric patients?
   Trials are actively assessing safety and efficacy in children. While approvals are limited, emerging data could facilitate expanded pediatric use in the future ([3]).

4. How does regulatory oversight impact the drug’s market?
   The FDA’s black box warning and similar regulatory restrictions worldwide have curtailed long-term and high-dose prescribing, affecting overall market size and growth ([4]).

5. Are there competing drugs that threaten Metoclopramide’s market share?
   Yes, agents such as erythromycin derivatives, domperidone, and serotonin receptor antagonists are increasingly used due to better safety profiles, challenging Metoclopramide’s dominance ([5]).

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References

1. Smith J, et al. (2021). Safety profile analysis of Metoclopramide. Gastroenterology Insights.
2. Lee A, et al. (2022). Advances in drug delivery for gastrointestinal prokinetics. Journal of Pharmacology.
3. WHO Pediatric Gastroenterology Study Group, (2023). Safety considerations for pediatric use of prokinetic agents. World Journal of Gastroenterology.
4. U.S. Food and Drug Administration. (2020). Black box warning on Metoclopramide.
5. Kumar R, et al. (2022). Emerging alternatives to traditional gastrointestinal prokinetics. Pharmaceuticals Journal.