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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 4

Conditions

Diarrhea

Treatments

Drug: loperamide-simethicone

Drug: matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00685607

LOPDIR4003

Details and patient eligibility

About

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.

Full description

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).

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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