CLINICAL TRIALS PROFILE FOR LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

All Clinical Trials for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00685607 ↗	Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 4	2008-10-01	For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.
NCT00778115 ↗	Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2004-11-01	The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in healthy subjects under fasting condition
NCT02217982 ↗	Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation	Terminated	Biogen	Phase 4	2014-07-01	Single site, open label, randomized design in patients with relapsing forms of Multiple Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF), including the titration period. After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater than or equal to 3.5 in at least one of the key categories will be randomized to a standard therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period will be terminated from the study at this visit. Patients with an average reported MAGIS of greater than 6.5 at Baseline will be placed in the treatment arm. Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily. Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily. Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will be recorded for one more week and collected at Week 7/End of Study.
NCT02217982 ↗	Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation	Terminated	Rocky Mountain MS Research Group, LLC	Phase 4	2014-07-01	Single site, open label, randomized design in patients with relapsing forms of Multiple Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF), including the titration period. After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater than or equal to 3.5 in at least one of the key categories will be randomized to a standard therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period will be terminated from the study at this visit. Patients with an average reported MAGIS of greater than 6.5 at Baseline will be placed in the treatment arm. Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily. Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily. Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will be recorded for one more week and collected at Week 7/End of Study.
NCT02340481 ↗	Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence	Completed	Xian-Janssen Pharmaceutical Ltd.	Phase 3	2005-07-01	The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.
NCT04186936 ↗	A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers	Completed	McNeil AB	Phase 1	2019-12-05	The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg (co-administered with Espumisan capsules with simethicone 40 mg), with respect to the single-dose pharmacokinetics of loperamide HCl. The maximum observed concentration (Cmax), and the area under the concentration-vs.-time curve until the last measurable concentration (AUC [0-t]) will be used to assess bioequivalence.

Clinical Trial Conditions for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Condition Name

Condition Name for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Intervention	Trials
Diarrhea	2
Healthy	2
Relapsing Remitting Multiple Sclerosis	1

Condition MeSH

Condition MeSH for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Intervention	Trials
Diarrhea	2
Multiple Sclerosis, Relapsing-Remitting	1
Multiple Sclerosis	1
Flatulence	1

Clinical Trial Locations for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Trials by Country

Trials by Country for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Location	Trials
United States	2
Mexico	1
Russian Federation	1
China	1

Trials by US State

Trials by US State for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Location	Trials
Utah	1
Missouri	1

Clinical Trial Progress for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Clinical Trial Phase

Clinical Trial Phase for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Sponsor Name

Sponsor Name for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Sponsor	Trials
Johnson & Johnson Consumer and Personal Products Worldwide	1
Ranbaxy Laboratories Limited	1
Biogen	1

Sponsor Type

Sponsor Type for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Sponsor	Trials
Industry	5
Other	1

Last updated: May 2, 2026

Loperamide Hydrochloride and Simethicone (Oral, Fixed-Dose Combo): Clinical Trials Update, Market Analysis, and Projection

What is the current clinical-trials posture for loperamide HCl + simethicone?

No complete, reliable clinical-trials update can be produced from the information provided. A precise posture requires an auditable base of: (i) active and completed interventional studies, (ii) trial phases and endpoints (e.g., stool frequency reduction for diarrhea; flatulence/abdominal discomfort endpoints for gas/bloating), (iii) dosing arms for the fixed-dose combo, and (iv) geography and sponsor details. Without that trial registry data, any “update” would be non-actionable.

How does market structure look for loperamide + simethicone?

A market analysis also requires verifiable inputs that are not present here: unit sales by geography, branded versus generic mix, price points, channel breakdown (pharmacy versus OTC), and competitor mapping for the same indication and regimen. Without such data, a projection would be speculative.

What is the market size and share outlook?

No defensible market sizing or forecast can be produced without numeric baselines (current sales, growth rates by region, and category dynamics for antidiarrheals and anti-gas agents). The request implies projections, which must be anchored to data sources (e.g., IQVIA, public pharma reports, regulatory product listings with pricing or volume proxies). Those sources are not included in the prompt.

Which regulatory and product-formulation facts are required for a correct projection?

A projection for a fixed-dose OTC-style combo hinges on product specifics that drive substitution risk and survivability through generics:

• Strengths and formulation (mg of loperamide HCl per unit plus simethicone mg; tablet vs capsule vs liquid).
• Target label (diarrhea with gas/bloating versus nonspecific GI discomfort).
• Indication language and limitations (e.g., dehydration warning; blood in stool exclusions; age restrictions).
• OTC versus behind-the-counter status by country.
• Packaging and dosing frequency that affects compliance and repeat-purchase rate.

None of these facts are provided, and without them, no projection can be made without inventing the unit economics.

What is the most actionable way to treat this request as a deliverable?

The only deliverable that can be produced accurately from the information given is a framework of what must be compiled, not a fabricated update. Under the constraints, no clinical-trials update, market analysis, or numeric projection can be issued.

Key Takeaways

• A clinical-trials update for loperamide HCl + simethicone requires verifiable registry results (study status, phase, endpoints, dosing arms, geography). None are provided, so no update can be issued.
• A market analysis and projection require numeric baselines (sales, pricing, category growth, channel mix, competitor mapping). None are provided, so no projection can be issued.
• Fixed-dose combo forecasts must be tied to exact formulation and label scope to model substitution risk, which is not provided.

FAQs

1. Is loperamide HCl + simethicone commonly studied in late-stage clinical trials?
   A definitive answer requires trial registry evidence (phase distribution and completion status).

2. Does market performance depend more on diarrhea demand or on gas/bloating demand?
   A quantified answer depends on label scope, endpoint positioning, and sales attribution by indication, which are not provided.

3. How do generics affect long-term revenue for this combo?
   The impact depends on formulation equivalency and regulatory entry timing by country, which requires product-level data.

4. What are the highest-leverage endpoints for differentiation?
   For diarrhea: stool frequency reduction and urgency; for gas/bloating: bloating score and discomfort reduction. A mapping to actual trials is not possible without trial identifiers.

5. What horizon is appropriate for a market projection?
   Typically 3 to 10 years for revenue modeling, but horizon selection and numeric forecast require baseline market sizing and growth drivers.

References

No sources were provided in the prompt, and none can be cited without introducing uncited factual claims.