Back to resultsEfficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Loperamide hydrochloride + simethicone chewable tablet
Loperamide hydrochloride
Loperamide hydrochloride + simethicone chewable placebo tablet
Loperamide hydrochloride placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea, Flatulence, Abdominal discomfort, Loperamide hydrochloride, Simethicone, Placebo
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Loperamide Hydrochloride + Simethicone
Loperamide Hydrochloride
Arm Description
Participant will take 2 loperamide hydrochloride and simethicone chewable tablets + 2 loperamide hydrochloride placebo capsules orally, as their first dose, and subsequently 1 loperamide hydrochloride and simethicone chewable tablet + 1 loperamide hydrochloride placebo capsule orally, in the event of unformed stool (provided that no more than 4 tablets/capsules are taken within a 24-hour period) up to 48 hours.
Participant will take 2 loperamide hydrochloride capsules + 2 loperamide hydrochloride and simethicone chewable placebo tablets orally, as their first dose, and subsequently 1 loperamide hydrochloride capsule + 1 loperamide hydrochloride and simethicone chewable placebo tablet orally, in the event of unformed stool (provided that no more than 4 capsules/tablets are taken within a 24-hour period) up to 48 hours.
Outcomes
Primary Outcome Measures
Time to Last Unformed Stool (TTLUS)
The TTLUS is defined as the number of hours from the time the participant first took the trial drug to the last instance of unformed stool, after which the participant only reported formed stool or no stool at all. If no unformed stool was observed at any time during the trial, TTLUS shall be recorded as 0. For participants who withdraw from the trial due to reasons other than complete resolution of the symptoms of diarrhea, TTLUS is defined as the number of hours from the start of the trial to the time of withdrawal.
Time to Complete Amelioration of Abdominal Discomfort
The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.
Secondary Outcome Measures
Number of Participants With Complete Remission of Diarrhea
Participants who do not produce any unformed stool within 24 hours of producing their last unformed stool shall be regarded as completely resolved of any diarrhea symptoms.
Number of Unformed Stools
Number of unformed stools produced from first drug administration to the end of treatment.
Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment
Number of Participants With Complete Remission of Abdominal Discomfort
Severity of Abdominal Discomfort
Each participant will evaluate any abdominal bloating and/or abdominal pain and/or any other type of abdominal discomfort caused by gastrointestinal gas accumulation occurring within the last hour on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = relatively severe, 4 = severe).
Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort
Participant and Investigator's Overall Evaluations of the Treatment
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Full Information
NCT ID
NCT02340481
First Posted
January 13, 2015
Last Updated
January 6, 2016
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02340481
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Diarrhea, Flatulence, Abdominal discomfort, Loperamide hydrochloride, Simethicone, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loperamide Hydrochloride + Simethicone
Arm Type
Experimental
Arm Description
Participant will take 2 loperamide hydrochloride and simethicone chewable tablets + 2 loperamide hydrochloride placebo capsules orally, as their first dose, and subsequently 1 loperamide hydrochloride and simethicone chewable tablet + 1 loperamide hydrochloride placebo capsule orally, in the event of unformed stool (provided that no more than 4 tablets/capsules are taken within a 24-hour period) up to 48 hours.
Arm Title
Loperamide Hydrochloride
Arm Type
Active Comparator
Arm Description
Participant will take 2 loperamide hydrochloride capsules + 2 loperamide hydrochloride and simethicone chewable placebo tablets orally, as their first dose, and subsequently 1 loperamide hydrochloride capsule + 1 loperamide hydrochloride and simethicone chewable placebo tablet orally, in the event of unformed stool (provided that no more than 4 capsules/tablets are taken within a 24-hour period) up to 48 hours.
Intervention Type
Drug
Intervention Name(s)
Loperamide hydrochloride + simethicone chewable tablet
Intervention Description
Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.
Intervention Type
Drug
Intervention Name(s)
Loperamide hydrochloride
Intervention Description
Each capsule contains 2 mg of loperamide hydrochloride
Intervention Type
Drug
Intervention Name(s)
Loperamide hydrochloride + simethicone chewable placebo tablet
Intervention Description
Placebo matched to loperamide hydrochloride and simethicone chewable tablet.
Intervention Type
Drug
Intervention Name(s)
Loperamide hydrochloride placebo capsule
Intervention Description
Placebo matched to loperamide hydrochloride capsule.
Primary Outcome Measure Information:
Title
Time to Last Unformed Stool (TTLUS)
Description
The TTLUS is defined as the number of hours from the time the participant first took the trial drug to the last instance of unformed stool, after which the participant only reported formed stool or no stool at all. If no unformed stool was observed at any time during the trial, TTLUS shall be recorded as 0. For participants who withdraw from the trial due to reasons other than complete resolution of the symptoms of diarrhea, TTLUS is defined as the number of hours from the start of the trial to the time of withdrawal.
Time Frame
48 hours
Title
Time to Complete Amelioration of Abdominal Discomfort
Description
The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Complete Remission of Diarrhea
Description
Participants who do not produce any unformed stool within 24 hours of producing their last unformed stool shall be regarded as completely resolved of any diarrhea symptoms.
Time Frame
Up to 48 hours
Title
Number of Unformed Stools
Description
Number of unformed stools produced from first drug administration to the end of treatment.
Time Frame
Up to 48 hours
Title
Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment
Time Frame
48 hours
Title
Number of Participants With Complete Remission of Abdominal Discomfort
Time Frame
Up to 48 hours
Title
Severity of Abdominal Discomfort
Description
Each participant will evaluate any abdominal bloating and/or abdominal pain and/or any other type of abdominal discomfort caused by gastrointestinal gas accumulation occurring within the last hour on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = relatively severe, 4 = severe).
Time Frame
Up to 48 hours
Title
Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort
Time Frame
48 hours
Title
Participant and Investigator's Overall Evaluations of the Treatment
Time Frame
48 hours
Title
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Guangzhou
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
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