Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

• Time to improvement in stool form [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement in urge to defecate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement in gas-related abdominal discomfort [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement of change in normal activities of daily living [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Subject global impression of efficacy of study medication at the end of the treatment period [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

• Time to improvement in stool form [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement in urge to defecate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement in gas-related abdominal discomfort [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Time to improvement of change in normal activities of daily living [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Subject global impression of efficacy of study medication at the end of the treatment period [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

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.

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

• Drug: loperamide-simethicone
  Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
  Other Name: Imodium
• Drug: matching placebo
  Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
  Other Name: Placebo

• Experimental: 1
  loperamide-simethicone
  Intervention: Drug: loperamide-simethicone
• Placebo Comparator: 2
  matching placebo
  Intervention: Drug: matching placebo

Inclusion Criteria:

• Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
• Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
• Able to understand the informed consent process and sign the form
• Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.

Exclusion Criteria:

• Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
• Illness requires hospitalization, IV fluids or antibiotics
• Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
• History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
• History of hypersensitivity to loperamide or simethicone
• Has previously participated in this study or received an investigational drug within the 30 day period before screening