NCT02340481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

January 13, 2015

Last Update Submit

January 6, 2016

Conditions

Diarrhea

Keywords

DiarrheaFlatulenceAbdominal discomfortLoperamide hydrochlorideSimethiconePlacebo

Outcome Measures

Primary Outcomes (2)

  • 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

  • Time to Complete Amelioration of Abdominal Discomfort

    The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.

    48 hours

Secondary Outcomes (8)

  • Number of Participants With Complete Remission of Diarrhea

    Up to 48 hours

  • Number of Unformed Stools

    Up to 48 hours

  • Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment

    48 hours

  • Number of Participants With Complete Remission of Abdominal Discomfort

    Up to 48 hours

  • Severity of Abdominal Discomfort

    Up to 48 hours

  • +3 more secondary outcomes

Study Arms (2)

Loperamide Hydrochloride + Simethicone

EXPERIMENTAL

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 tabletDrug: Loperamide hydrochloride placebo capsule

Loperamide Hydrochloride

ACTIVE COMPARATOR

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 hydrochlorideDrug: Loperamide hydrochloride + simethicone chewable placebo tablet

Interventions

Loperamide hydrochloride + simethicone chewable tabletDRUG

Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.

Loperamide Hydrochloride + Simethicone
Loperamide hydrochlorideDRUG

Each capsule contains 2 mg of loperamide hydrochloride

Loperamide Hydrochloride
Loperamide hydrochloride + simethicone chewable placebo tabletDRUG

Placebo matched to loperamide hydrochloride and simethicone chewable tablet.

Loperamide Hydrochloride
Loperamide hydrochloride placebo capsuleDRUG

Placebo matched to loperamide hydrochloride capsule.

Loperamide Hydrochloride + Simethicone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

MeSH Terms

Conditions

DiarrheaFlatulence

Interventions

Loperamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

July 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

CN(4)