Status:
COMPLETED
Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00685607
Start Date
October 1 2008
End Date
October 1 2008
Last Update
October 6 2011
Active Locations (1)
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1
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico, 44100