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Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02340481
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Loperamide hydrochloride + simethicone chewable tablet Drug: Loperamide hydrochloride Drug: Loperamide hydrochloride + simethicone chewable placebo tablet Drug: Loperamide hydrochloride placebo capsule Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Gas

Arm Intervention/treatment
Experimental: Loperamide Hydrochloride + Simethicone
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.
Drug: Loperamide hydrochloride + simethicone chewable tablet
Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.

Drug: Loperamide hydrochloride placebo capsule
Placebo matched to loperamide hydrochloride capsule.

Active Comparator: Loperamide Hydrochloride
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.
Drug: Loperamide hydrochloride
Each capsule contains 2 mg of loperamide hydrochloride

Drug: Loperamide hydrochloride + simethicone chewable placebo tablet
Placebo matched to loperamide hydrochloride and simethicone chewable tablet.




Primary Outcome Measures :
  1. Time to Last Unformed Stool (TTLUS) [ Time Frame: 48 hours ]
    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.

  2. Time to Complete Amelioration of Abdominal Discomfort [ Time Frame: 48 hours ]
    The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.


Secondary Outcome Measures :
  1. Number of Participants With Complete Remission of Diarrhea [ Time Frame: Up to 48 hours ]
    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.

  2. Number of Unformed Stools [ Time Frame: Up to 48 hours ]
    Number of unformed stools produced from first drug administration to the end of treatment.

  3. Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment [ Time Frame: 48 hours ]
  4. Number of Participants With Complete Remission of Abdominal Discomfort [ Time Frame: Up to 48 hours ]
  5. Severity of Abdominal Discomfort [ Time Frame: Up to 48 hours ]
    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).

  6. Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort [ Time Frame: 48 hours ]
  7. Participant and Investigator's Overall Evaluations of the Treatment [ Time Frame: 48 hours ]
  8. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to 48 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340481


Locations
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China
Beijing, China
Guangzhou, China
Nanjing, China
Shanghai, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
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Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.

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Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT02340481    
Other Study ID Numbers: CR103534
LOPDIR3001 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Diarrhea
Flatulence
Abdominal discomfort
Loperamide hydrochloride
Simethicone
Placebo
Additional relevant MeSH terms:
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Diarrhea
Flatulence
Signs and Symptoms, Digestive
Signs and Symptoms
Simethicone
Loperamide
Antidiarrheals
Gastrointestinal Agents
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents