CClinicalTrials.gg
Sign In
CompletedNCT00685607Updated Oct 6, 2011

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

A Phase 4 interventional study of loperamide-simethicone and matching placebo in Diarrhea, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-06.

Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

Read the detailed description

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

02

Conditions studied

  • Diarrhea

Browse trials for

Keywords

  • Pilot Study
  • Outcome Measures
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 45 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
  • Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
  • Able to understand the informed consent process and sign the form
  • Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.

Exclusion criteria

Exclusion Criteria:

  • Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
  • Illness requires hospitalization, IV fluids or antibiotics
  • Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
  • History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
  • History of hypersensitivity to loperamide or simethicone
  • Has previously participated in this study or received an investigational drug within the 30 day period before screening
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    1

    loperamide-simethicone

    Drug: loperamide-simethicone

  • Placebo comparator
    2

    matching placebo

    Drug: matching placebo

Interventions

  • Drugloperamide-simethicone

    Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.

    Also known as: Imodium

  • Drugmatching placebo

    Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Evaluate Multiple Endpoints

    Time frame: 6 hours

Secondary outcomes

  1. Time to improvement in stool form

    Time frame: 6 hours

  2. Time to improvement in urge to defecate

    Time frame: 6 hours

  3. Time to improvement in gas-related abdominal discomfort

    Time frame: 6 hours

  4. Time to improvement of change in normal activities of daily living

    Time frame: 6 hours

  5. Subject global impression of efficacy of study medication at the end of the treatment period

    Time frame: 6 hours

  6. Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study

    Time frame: 6 hours

07

Study locations

1 site
  • Universidad Autonoma de Guadalajara
    Guadalajara, Jalisco 44100, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00685607
Lead sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Responsible party
Sponsor
First posted
May 28, 2008
Start date
Oct 2008
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Oct 6, 2011

Study contacts

Herbert L DuPont, MD
study chair · Department of Public Health, University of Texas, Houston School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diarrhea→

Other studies from this sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Start the discussion