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Last Updated: January 15, 2025

CLINICAL TRIALS PROFILE FOR IMODIUM MULTI-SYMPTOM RELIEF


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All Clinical Trials for IMODIUM MULTI-SYMPTOM RELIEF

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.
NCT00292344 ↗ Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea Completed The University of Texas Health Science Center, Houston 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 MULTI-SYMPTOM RELIEF

Condition Name

Condition Name for IMODIUM MULTI-SYMPTOM RELIEF
Intervention Trials
Diarrhea 5
Fecal Incontinence 3
Travelers' Diarrhea 2
Healthy 2
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Condition MeSH

Condition MeSH for IMODIUM MULTI-SYMPTOM RELIEF
Intervention Trials
Diarrhea 10
Fecal Incontinence 3
Breast Neoplasms 2
Rectal Neoplasms 2
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Clinical Trial Locations for IMODIUM MULTI-SYMPTOM RELIEF

Trials by Country

Trials by Country for IMODIUM MULTI-SYMPTOM RELIEF
Location Trials
United States 59
Mexico 6
Spain 3
India 1
Kenya 1
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Trials by US State

Trials by US State for IMODIUM MULTI-SYMPTOM RELIEF
Location Trials
California 5
Texas 5
North Carolina 4
Pennsylvania 2
Ohio 2
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Clinical Trial Progress for IMODIUM MULTI-SYMPTOM RELIEF

Clinical Trial Phase

Clinical Trial Phase for IMODIUM MULTI-SYMPTOM RELIEF
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 MULTI-SYMPTOM RELIEF
Clinical Trial Phase Trials
Completed 12
Terminated 5
Active, not recruiting 2
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Clinical Trial Sponsors for IMODIUM MULTI-SYMPTOM RELIEF

Sponsor Name

Sponsor Name for IMODIUM MULTI-SYMPTOM RELIEF
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 MULTI-SYMPTOM RELIEF
Sponsor Trials
Other 29
Industry 18
U.S. Fed 4
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IMODIUM Multi-Symptom Relief: Clinical Trials, Market Analysis, and Projections

Introduction to IMODIUM Multi-Symptom Relief

IMODIUM Multi-Symptom Relief is a widely recognized over-the-counter (OTC) anti-diarrheal medication that combines the active ingredients Loperamide HCl and Simethicone. This unique combination provides fast relief from acute diarrhea and associated gas-related abdominal discomfort, including symptoms of gas, bloating, cramps, and pressure[1].

Clinical Trials and Efficacy

Mechanism of Action

Loperamide, the primary active ingredient in IMODIUM, works by reducing the frequency of bowel movements and relieving diarrhea by increasing the tone of the anal sphincter and reducing incontinence and urgency. It prolongs the transit time of intestinal contents, reduces daily fecal volume, and diminishes the loss of fluid and electrolytes[5].

Clinical Studies

Clinical studies have demonstrated the efficacy of loperamide in managing acute and chronic diarrhea. These studies have shown that loperamide has a low abuse potential and does not lead to tolerance over time. Patients in clinical trials experienced significant improvement in symptoms within 48 hours, with no trends toward abnormality in biochemical, hematological, or other monitored parameters[5].

Specific Use in Chemotherapy-Induced Diarrhea (CID)

Research has also focused on the use of loperamide for Chemotherapy-Induced Diarrhea (CID). Clinical trials and assessments have highlighted the safety and efficacy of loperamide in this context, providing detailed information on trial interventions, conditions, and outcomes. These studies support the use of loperamide as a viable treatment option for CID, especially in regions like the United States, EU4, the UK, and Japan[4].

Market Analysis

Global Antidiarrheal Drug Market

The global Antidiarrheal Drug market is projected to grow significantly, with an estimated size of USD 102154.2 million in 2024. This market is expected to expand at a compound annual growth rate (CAGR) of 5.20% from 2024 to 2031. North America, Europe, and the Asia Pacific region are key markets, with North America holding over 40% of the global revenue[3].

OTC Segment Dominance

OTC drugs, such as IMODIUM, are expected to dominate the Antidiarrheal Drug market due to their ease of accessibility, affordability, and widespread use for managing common diarrhea symptoms. Brands like IMODIUM and Pepto-Bismol are consumer favorites, driven by strong brand recognition and the growing trend of self-medication[3].

Prescription Segment Growth

While OTC drugs dominate, the prescription segment is also growing, particularly for chronic conditions like irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). These conditions require more targeted, long-term treatments, driving demand for advanced prescription medications[3].

Market Projections

Loperamide HCI Market

The Loperamide HCI market is anticipated to grow due to increasing awareness of antidiarrheal drugs with fewer side effects and rising government initiatives for healthcare improvements. Developing countries, with large populations facing diarrhea due to improper eating habits, offer significant growth potential for this market[2].

Regional Market Analysis

  • North America: Expected to maintain a significant market share, driven by high healthcare spending and advanced healthcare facilities.
  • Europe: Holds a substantial market share, with a CAGR of 3.7% from 2024 to 2031.
  • Asia Pacific: Projected to grow at a CAGR of 7.2% from 2024 to 2031, driven by a large population and increasing healthcare needs[3].

Sales Forecast for CID

For Chemotherapy-Induced Diarrhea, the market assessment forecasts significant sales growth from 2024 to 2032, particularly in major markets such as the United States, EU4, the UK, and Japan. This growth is supported by detailed clinical trials and regulatory milestones[4].

Competitive Landscape

Marketed Therapies

IMODIUM Multi-Symptom Relief stands out as a unique OTC product that combines Loperamide and Simethicone, offering comprehensive relief from multiple symptoms associated with diarrhea. This combination sets it apart from other antidiarrheal medications, making it a preferred choice for consumers[1].

Emerging Therapies

The market is also seeing the emergence of new therapies, particularly for chronic conditions. However, loperamide remains a widely used and trusted option for both acute and chronic diarrhea management due to its proven efficacy and safety profile[3][4].

Key Takeaways

  • Clinical Efficacy: IMODIUM Multi-Symptom Relief has been clinically proven to effectively manage acute and chronic diarrhea, including symptoms of gas, bloating, cramps, and pressure.
  • Market Dominance: OTC drugs like IMODIUM dominate the antidiarrheal market due to their accessibility and widespread use.
  • Regional Growth: Significant growth is projected in North America, Europe, and the Asia Pacific region.
  • CID Market: Loperamide is a key treatment option for Chemotherapy-Induced Diarrhea, with forecasted sales growth from 2024 to 2032.

FAQs

What are the active ingredients in IMODIUM Multi-Symptom Relief?

The active ingredients are Loperamide HCl 2 mg and Simethicone 125 mg per caplet[1].

How does Loperamide work?

Loperamide works by reducing the frequency of bowel movements, increasing the tone of the anal sphincter, and prolonging the transit time of intestinal contents[5].

What are the contraindications for using IMODIUM?

IMODIUM is contraindicated in patients with a known hypersensitivity to Loperamide, bloody or black stools, difficulty swallowing, and certain other conditions. It is also advised to consult a doctor before use in cases of fever, mucus in the stool, or a history of liver disease[1].

Can IMODIUM be used for Chemotherapy-Induced Diarrhea?

Yes, loperamide is used for managing Chemotherapy-Induced Diarrhea, supported by clinical trials and market assessments[4].

What is the projected growth rate of the global Antidiarrheal Drug market?

The global Antidiarrheal Drug market is expected to grow at a CAGR of 5.20% from 2024 to 2031[3].

Sources

  1. IMODIUMĀ® Multi-Symptom Relief Anti-Diarrheal Medicine Caplets. IMODIUM.
  2. Loperamide HCI Market Size | Trends | Growth | Scope | Forecast. Verified Market Research.
  3. Antidiarrheal Drug Market Report 2024 (Global Edition). Cognitive Market Research.
  4. Loperamide for Chemotherapy-Induced Diarrhea Research 2024. Business Wire.
  5. IMODIUMĀ® (loperamide hydrochloride). FDA.

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