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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR IMODIUM A-D


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All Clinical Trials for Imodium A-d

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

Condition Name

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

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

Trials by Country

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

Clinical Trial Phase

Clinical Trial Phase for Imodium A-d
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
Clinical Trial Phase Trials
Completed 12
Terminated 5
Active, not recruiting 2
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Clinical Trial Sponsors for Imodium A-d

Sponsor Name

Sponsor Name for Imodium A-d
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
Sponsor Trials
Other 29
Industry 18
U.S. Fed 4
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Imodium A-D: Clinical Trials, Market Analysis, and Projections

Introduction to Imodium A-D

Imodium A-D, containing the active ingredient loperamide, is a widely used medication for treating diarrhea, including traveler's diarrhea and irritable bowel syndrome with diarrhea (IBS-D). Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Safety Concerns

Recent Regulatory Actions

In response to the misuse and abuse of loperamide, the U.S. Food and Drug Administration (FDA) has taken significant steps. As of September 2019, the FDA limited the package sizes for over-the-counter (OTC) loperamide products, such as Imodium A-D and Imodium Multi-Symptom Relief, to curb abuse. The new packaging limits each carton to no more than 48 mg of loperamide and requires unit-dose blister packaging[1][2].

Clinical Trials for Specific Indications

Loperamide is being studied for various indications beyond its traditional use for diarrhea. For example, there is ongoing research on its efficacy in treating chemotherapy-induced diarrhea (CID). Clinical trials are assessing the safety and efficacy of loperamide in this context, including trial interventions, trial conditions, and trial status. These studies aim to provide comprehensive data on the use of loperamide for CID across major markets such as the United States, Europe, and Japan[3].

Safety and Efficacy

Clinical studies have consistently supported the efficacy of loperamide in treating acute diarrhea. For instance, a multicentre double-blind study comparing loperamide with other antidiarrheal agents and a placebo showed that loperamide significantly reduced the number of unformed stools and delayed the time to the first liquid stool[4].

However, it is crucial to note that loperamide can cause serious cardiac events when taken in higher than recommended doses. These events include QT interval prolongation, torsades de pointes, syncope, and cardiac arrest. Healthcare professionals are advised to monitor patients for these adverse effects and to ensure that patients follow the recommended doses strictly[1].

Market Analysis

Global Market Outlook

The global loperamide market is expected to grow significantly over the forecast period (2024-2031). This growth is driven by increasing awareness of antidiarrheal drugs with fewer adverse effects and the rising incidence of gastrointestinal disorders such as IBS-D. The market is also influenced by regulatory changes aimed at reducing the misuse of loperamide[2][5].

Competitive Landscape

The loperamide market is competitive, with several key players involved in the development and marketing of loperamide products. The market competition landscape includes a detailed analysis of the value, market share, and development plans of these players. Reports such as those from Global Info Research provide insights into the competitive dynamics and global outlook for the loperamide market[2][5].

Regional Market Analysis

The market for loperamide is analyzed across various regions, including the United States, Europe (Germany, France, Italy, Spain, and the UK), and Japan. These regions are expected to contribute significantly to the growth of the loperamide market, driven by the increasing demand for effective antidiarrheal medications. The report from ResearchAndMarkets.com provides a detailed market assessment, including forecasted sales data for these regions from 2024 to 2032[3].

Market Projections

Forecasted Sales

The loperamide market is projected to experience substantial growth, with forecasted sales increasing over the next decade. For chemotherapy-induced diarrhea, the market is expected to see significant growth, driven by the increasing incidence of cancer and the need for effective treatments for CID. The forecasted sales data indicate a promising future for loperamide in this segment[3].

Emerging Trends and Challenges

The market for loperamide is also influenced by emerging trends and challenges. The rise of biosimilars and other antidiarrheal medications presents both opportunities and challenges. Additionally, the ongoing need to address the misuse and abuse of loperamide will continue to shape the market landscape[1][2].

Key Takeaways

  • Regulatory Actions: The FDA has limited package sizes and implemented unit-dose blister packaging to curb loperamide abuse.
  • Clinical Trials: Ongoing trials are assessing loperamide's efficacy for chemotherapy-induced diarrhea.
  • Safety Concerns: High doses of loperamide can lead to serious cardiac events, emphasizing the need for adherence to recommended doses.
  • Market Growth: The global loperamide market is expected to grow significantly, driven by increasing demand for antidiarrheal medications.
  • Regional Analysis: The market is analyzed across major regions, with forecasted sales data indicating strong growth.

FAQs

What are the recent regulatory changes affecting Imodium A-D?

The FDA has limited the package sizes for OTC loperamide products to no more than 48 mg per carton and requires unit-dose blister packaging to curb abuse[1][2].

What are the potential risks associated with taking high doses of loperamide?

High doses of loperamide can lead to serious cardiac events, including QT interval prolongation, torsades de pointes, syncope, and cardiac arrest[1].

Is loperamide effective for chemotherapy-induced diarrhea?

Clinical trials are ongoing to assess the efficacy and safety of loperamide for chemotherapy-induced diarrhea. Initial data suggest it could be a viable treatment option[3].

What is the projected market growth for loperamide?

The global loperamide market is expected to grow significantly over the forecast period, driven by increasing demand for antidiarrheal medications and regulatory changes[2][3].

How does the misuse of loperamide impact its market?

The misuse and abuse of loperamide have led to regulatory actions and safety warnings, which can influence market dynamics and consumer behavior[1][2].

References

  1. FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin. The Rheumatologist, 2019.
  2. Loperamide Market Industry Share, Size: 2024 with Growth, Segments and Forecast - 2031. OpenPR, 2024.
  3. Loperamide for Chemotherapy-Induced Diarrhea Research 2024: Market Size, Regulatory Milestones, Sales Forecast, Patents, Insights. Business Wire, 2024.
  4. The IMODIUMĀ® Difference. Kenvue.
  5. Loperamide HCl Market Emerging by Trends and Shares During the Forecast Period (2020-2025). OpenPR, 2020.

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