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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Treatme

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 Summary: 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.
Sponsor: Xian-Janssen Pharmaceutical Ltd.

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • Number of Unformed Stools [ Time Frame: Up to 48 hours ]
    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 [ Time Frame: 48 hours ]
  • Number of Participants With Complete Remission of Abdominal Discomfort [ Time Frame: Up to 48 hours ]
  • 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).
  • Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort [ Time Frame: 48 hours ]
  • Participant and Investigator's Overall Evaluations of the Treatment [ Time Frame: 48 hours ]
  • 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.


Original Secondary Outcome: Same as current

Information By: Xian-Janssen Pharmaceutical Ltd.

Dates:
Date Received: January 13, 2015
Date Started: July 2005
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016