Diarrhea Clinical Trial
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
Verified date | January 2016 |
Source | Xian-Janssen Pharmaceutical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xian-Janssen Pharmaceutical Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 48 hours | No |
Primary | Time to Complete Amelioration of Abdominal Discomfort | The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved. | 48 hours | No |
Secondary | 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. | Up to 48 hours | No |
Secondary | Number of Unformed Stools | Number of unformed stools produced from first drug administration to the end of treatment. | Up to 48 hours | No |
Secondary | Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment | 48 hours | No | |
Secondary | Number of Participants With Complete Remission of Abdominal Discomfort | Up to 48 hours | No | |
Secondary | 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). | Up to 48 hours | No |
Secondary | Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort | 48 hours | No | |
Secondary | Participant and Investigator's Overall Evaluations of the Treatment | 48 hours | No | |
Secondary | 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. | Up to 48 hours | Yes |
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