Diarrhea
Conditions
Keywords
Pilot Study, Outcome Measures
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).
Interventions
DRUGloperamide-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.
DRUGmatching 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.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate Multiple Endpoints | 6 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to improvement in urge to defecate | 6 hours |
| Time to improvement in gas-related abdominal discomfort | 6 hours |
| Time to improvement in stool form | 6 hours |
| Subject global impression of efficacy of study medication at the end of the treatment period | 6 hours |
| Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study | 6 hours |
| Time to improvement of change in normal activities of daily living | 6 hours |
Countries
Mexico
Outcome results
None listed