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Generated: November 17, 2018

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CLINICAL TRIALS PROFILE FOR LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

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Clinical Trials for Loperamide Hydrochloride And Simethicone

Trial ID Title Status Sponsor Phase 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Loperamide Hydrochloride And Simethicone

Condition Name

Condition Name for Loperamide Hydrochloride And Simethicone
Intervention Trials
Diarrhea 2
Relapsing Remitting Multiple Sclerosis 1
Healthy 1
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Condition MeSH

Condition MeSH for Loperamide Hydrochloride And Simethicone
Intervention Trials
Diarrhea 2
Flatulence 1
Multiple Sclerosis, Relapsing-Remitting 1
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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
China 1
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Trials by US State

Trials by US State for Loperamide Hydrochloride And Simethicone
Location Trials
Utah 1
Missouri 1
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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
N/A 1
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Clinical Trial Status

Clinical Trial Status for Loperamide Hydrochloride And Simethicone
Clinical Trial Phase Trials
Completed 3
Terminated 1
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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
Xian-Janssen Pharmaceutical Ltd. 1
Rocky Mountain MS Research Group, LLC 1
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Sponsor Type

Sponsor Type for Loperamide Hydrochloride And Simethicone
Sponsor Trials
Industry 4
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Moodys
McKesson
US Army
Covington
US Department of Justice
QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo

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