Clinical trial NCT02340481: Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Official title: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Loperamide Hydrochloride/Simethicone Chewable Tablet in the Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: Diarrhea
Flatulence
Abdominal discomfort
Loperamide hydrochloride
Simethicone
Placebo
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.

Detailed description: This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group (each group of participants will be treated at the same time), multi-center (when more than one hospital or medical school team work on a medical research study) study. All eligible participants will be randomly assigned to receive either a combination of loperamide hydrochloride and simethicone or loperamide hydrochloride. The study includes Screening Visit (from -24 to 0 hours), Baseline Visit (at 0 hour) and Concluding Visit (within 48 to 96 hours following the start of the trial). The timing of each bowel movement, stool characteristics and the degree and duration of abdominal discomfort caused by gastrointestinal gas accumulation will be recorded for each participant for 48 hours after the first trial drug administration. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial
* Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
* Participant's most recently produced stool must be unformed stool
* Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour"
* Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal

Exclusion Criteria:

* Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
* Participant shows an axillary temperature greater than (\>) 38.2 degrees Celsius (C) or an oral temperature \> 38.6 degrees C
* Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at \> 3 per high power field
* Participant shows a sitting systolic blood pressure less than (\<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure \< 60 mmHg
* Participant is unable to take medication orally or tolerate oral rehydration

Primary outcomes:
measure: Time to Last Unformed Stool (TTLUS)
timeFrame: 48 hours
measure: Time to Complete Amelioration of Abdominal Discomfort
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Participants With Complete Remission of Diarrhea
timeFrame: Up to 48 hours
measure: Number of Unformed Stools
timeFrame: Up to 48 hours
measure: Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment
timeFrame: 48 hours
measure: Number of Participants With Complete Remission of Abdominal Discomfort
timeFrame: Up to 48 hours
measure: Severity of Abdominal Discomfort
timeFrame: Up to 48 hours
measure: Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort
timeFrame: 48 hours
measure: Participant and Investigator's Overall Evaluations of the Treatment
timeFrame: 48 hours
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: