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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR IMODIUM A-D EZ CHEWS


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All Clinical Trials for Imodium A-d Ez Chews

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00075868 ↗ Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Completed National Cancer Institute (NCI) Phase 3 2003-12-01 RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00075868 ↗ Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Completed Radiation Therapy Oncology Group Phase 3 2003-12-01 RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00292344 ↗ Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea Completed Bausch Health Americas, Inc. Phase 4 2004-06-01 Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00292344 ↗ Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea Completed Valeant Pharmaceuticals International, Inc. Phase 4 2004-06-01 Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Imodium A-d Ez Chews

Condition Name

Condition Name for Imodium A-d Ez Chews
Intervention Trials
Diarrhea 5
Fecal Incontinence 3
Travelers' Diarrhea 2
Healthy 2
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Condition MeSH

Condition MeSH for Imodium A-d Ez Chews
Intervention Trials
Diarrhea 10
Fecal Incontinence 3
Dysentery 2
Short Bowel Syndrome 2
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Clinical Trial Locations for Imodium A-d Ez Chews

Trials by Country

Trials by Country for Imodium A-d Ez Chews
Location Trials
United States 59
Mexico 6
Spain 3
Kenya 1
Denmark 1
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Trials by US State

Trials by US State for Imodium A-d Ez Chews
Location Trials
California 5
Texas 5
North Carolina 4
Missouri 2
Minnesota 2
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Clinical Trial Progress for Imodium A-d Ez Chews

Clinical Trial Phase

Clinical Trial Phase for Imodium A-d Ez Chews
Clinical Trial Phase Trials
Phase 4 6
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Imodium A-d Ez Chews
Clinical Trial Phase Trials
Completed 12
Terminated 5
Withdrawn 2
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Clinical Trial Sponsors for Imodium A-d Ez Chews

Sponsor Name

Sponsor Name for Imodium A-d Ez Chews
Sponsor Trials
M.D. Anderson Cancer Center 2
Johnson & Johnson Consumer and Personal Products Worldwide 2
McNeil AB 2
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Sponsor Type

Sponsor Type for Imodium A-d Ez Chews
Sponsor Trials
Other 29
Industry 18
U.S. Fed 4
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Loperamide in Imodium A-D EZ Chews: Clinical Trials, Market Analysis, and Projections

Introduction to Loperamide and Imodium A-D EZ Chews

Loperamide, the active ingredient in Imodium A-D EZ Chews, is a synthetic antidiarrheal agent that functions by decreasing intestinal motility without significant systemic absorption. It is widely used to control symptoms of diarrhea, including traveler’s diarrhea, and associated gas symptoms such as abdominal pain, bloating, and cramping[2][4].

Clinical Trials Update

Mechanism of Action and Efficacy

Loperamide works by directly affecting the smooth muscle of the intestine, reducing the frequency of bowel movements and stool weight. Clinical trials have demonstrated its effectiveness in reducing fecal incontinence and the frequency of bowel movements, making it a recommended treatment for various types of diarrhea, including chemotherapy-induced diarrhea (CID)[3][4].

Clinical Trials for Chemotherapy-Induced Diarrhea (CID)

Recent reports highlight the ongoing clinical trials and research on loperamide for CID. These trials focus on the safety, efficacy, and optimal dosage of loperamide in managing CID. The trials cover various aspects, including trial interventions, trial conditions, and the status of ongoing and completed studies. The data from these trials support the use of loperamide as an effective treatment for CID, with recommendations based on the reduction in fecal incontinence and bowel movement frequency[3].

Safety and Adverse Effects

While loperamide is generally well-tolerated, clinical trials and post-marketing surveillance have identified potential risks, particularly with higher-than-recommended dosages. These include torsades de pointes, cardiac arrest, and sudden death. Therefore, it is crucial to adhere to the recommended dosages, especially in pediatric patients and those with certain health conditions[4].

Market Analysis

Current Market Status

Imodium A-D EZ Chews, containing loperamide hydrochloride, are available over-the-counter (OTC) in various countries. The market for loperamide is significant, given its widespread use for treating different types of diarrhea. The drug is marketed by several companies, including McNeil Consumer Products, and is available in various dosage forms such as capsules, tablets, and chewable tablets[2][5].

Market Size and Forecast

The market assessment for loperamide, particularly for CID, is detailed in recent reports. These reports provide a comprehensive overview of the market size, forecasted sales, and competitive landscape in major markets including the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. The forecast indicates steady growth in the market for loperamide through 2032, driven by its efficacy in managing CID and other forms of diarrhea[3].

Competitive Landscape

The competitive landscape for antidiarrheal agents includes both marketed therapies and late-stage emerging therapies. Loperamide remains a dominant player due to its established efficacy and safety profile. However, other emerging therapies are also being developed to compete in the market for CID and other types of diarrhea. The SWOT analysis and analyst views provided in market reports help in understanding the strengths, weaknesses, opportunities, and threats for loperamide in this competitive environment[3].

Market Projections

Forecasted Sales

The forecasted sales data for loperamide in the seven major markets (7MM) indicate a positive growth trajectory. The report projects that the market for loperamide in CID will continue to expand from 2024 to 2032, driven by increasing incidence of chemotherapy-induced diarrhea and the drug's proven efficacy[3].

Country-Wise Market Analysis

The market analysis is detailed for each of the major countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Each country's market size and growth prospects are evaluated, providing a comprehensive picture of the global market for loperamide in CID[3].

Regulatory Milestones and Development Activities

The report also highlights the regulatory milestones and other developmental activities related to loperamide. This includes information on patents, licensing agreements, and collaborations that are crucial for the continued market presence and growth of loperamide[3].

Key Takeaways

  • Clinical Efficacy: Loperamide is highly effective in managing symptoms of diarrhea, including CID, by reducing intestinal motility.
  • Market Growth: The market for loperamide is projected to grow through 2032, driven by its efficacy and increasing incidence of CID.
  • Safety Considerations: Adherence to recommended dosages is critical to avoid serious adverse cardiac effects.
  • Competitive Landscape: Loperamide remains a dominant player in the antidiarrheal market, but faces competition from emerging therapies.
  • Regulatory and Development Activities: Ongoing regulatory milestones and developmental activities are crucial for the continued market success of loperamide.

FAQs

  1. What is the primary mechanism of action of loperamide in Imodium A-D EZ Chews?

    • Loperamide works by decreasing intestinal motility by directly affecting the smooth muscle of the intestine, without significant systemic absorption[3][4].
  2. What are the common adverse effects associated with loperamide?

    • Common adverse effects include nausea, constipation, abdominal cramps, and dizziness[4].
  3. Can loperamide be used in pediatric patients?

    • Yes, but with caution and adherence to recommended dosages. It is contraindicated in pediatric patients under 2 years of age[4].
  4. What is the market forecast for loperamide in chemotherapy-induced diarrhea (CID)?

    • The market for loperamide in CID is projected to grow through 2032, driven by its efficacy and increasing incidence of CID[3].
  5. Are there any emerging therapies competing with loperamide in the antidiarrheal market?

    • Yes, there are late-stage emerging therapies being developed to compete with loperamide in the market for CID and other types of diarrhea[3].

Sources

  1. CENTER FOR DRUG EVALUATION AND RESEARCH APPROVAL PACKAGE - FDA.
  2. Imodium A-D EZ chews - PharmaCompass.com.
  3. Loperamide for Chemotherapy-Induced Diarrhea Research 2024 - BusinessWire.
  4. Loperamide Monograph for Professionals - Drugs.com.
  5. IMODIUM® A-D Anti-Diarrheal Medicine Softgels - Imodium.com.

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