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AzTrials

DiarrheaPhase 4NCT00807326

A Comparison of Three Medications to Treat Diarrhea in Adults.

A Phase 4 study testing Loperamide/simeticone 2 mg/125 mg caplets, Loperamide/simeticone 2 mg/125 mg chewable tablets and Probiotic Saccharomyces boulardii 250 mg capsules in people with Diarrhea, run by McNeil AB at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A comparison of three medications to treat diarrhea in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diarrhea
What is being tested?
Loperamide/simeticone 2 mg/125 mg caplets, Loperamide/simeticone 2 mg/125 mg chewable tablets and Probiotic Saccharomyces boulardii 250 mg capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
6 sitesin 2 countries
Study dates
Nov 2008to Nov 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female at least 18 years of age
  • Acute diarrhea illness with symptoms onset within 48 hours of study entry
  • Minimum of 3 unformed stools in 24 hours before study entry
  • Most recent stool is unformed
  • Abdominal discomfort/wind (intensity mild to severe) within 4 hours of study entry
  • Women of childbearing potential must have a negative pregnancy test at screening
  • Willing to adhere to the prohibitions and restrictions specified in this protocol
  • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Who cannot join

  • Requiring hospital admission, parenteral hydration or antibiotic therapy Axillary temperature >38.2°C or oral temperature >38.6°C
  • History or clinical evidence of gross blood or pus in stool in current illness
  • Signs or symptoms of orthostatic hypotension
  • Unable to take medication and fluids by mouth
  • History of chronic gastrointestinal disease, hepatic or renal insufficiency, or other significant medical condition that could be aggravated by untreated acute diarrhea
  • Immunodeficiency (e.g. those with acquired immunodeficiency syndrome [AIDS] or known human immunodeficiency virus [HIV] infection, or undergoing chemotherapy or radiotherapy)
Show all 11Show fewer
  • Intake of antibiotics, oral antifungals, quinidine or ritonavir within 7 days, antidiarrhoeal, promotility drugs (e.g., metoclopramide, domperidone), antiflatulents (e.g., simeticone, activated charcoal) or probiotics or bismuth salts within 48 hours, or any analgesic within 6 hours prior to study entry Hypersensitivity to loperamide, yeast, or any component of study formulations
  • Pregnant or breast-feeding
  • Unable to comply with the protocol requirements and schedule
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study
  • Use of opiates (as 'recreational' drugs and as painkillers)

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Mexico4 sites

  • Hospital Amerimed Puerto Vallarta

    Puerto Vallarta, Jalisco, 48300

  • Servicios Medicos de la Bahia

    Puerto Vallarta, Jalisco, 48300

  • North West Medical

    San José del Cabo, Baja California Sur, 22447

  • Dr. Maxwell´s Clinic

    San Miguel de Allende, Guanuajuato, 37700

Other trials in Mexico

India2 sites

  • Manipal Goa Hospital

    Mormugao, Goa, 403004

  • Vrundavan Hospital & Research Centre

    Mormugao, Goa, 403527

Other trials in India

About this study

Official title: A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults

A comparison of three medications to treat diarrhea in adults.

Read the detailed description

This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.

Conditions
Diarrhea
Being tested
Loperamide/simeticone 2 mg/125 mg caplets, Loperamide/simeticone 2 mg/125 mg chewable tablets, Probiotic Saccharomyces boulardii 250 mg capsules
Keywords
Antidiarrheals
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loperamide/simeticone 2 mg/125 mg capletsDrug

    Also called Imodium® Plus Caplet

    Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)

  • Loperamide/simeticone 2 mg/125 mg chewable tabletsDrug

    Also called Imodium® Plus Chewable tablet

    Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)

  • Probiotic Saccharomyces boulardii 250 mg capsulesDrug

    Also called Perenterol® Forte 250mg capsules

    Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)

Study groups in NCT00807326
Study groupRoleWhat they receive
Loperamide/simeticone CapletsExperimentalDrug (including placebo)
Receives: Drug: Loperamide/simeticone 2 mg/125 mg caplets
Loperamide/simeticone Chewable TabletsActive comparatorDrug (including placebo)
Receives: Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets
Probiotic CapsulesActive comparatorDrug (including placebo)
Receives: Drug: Probiotic Saccharomyces boulardii 250 mg capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of unformed stools

    Measured: 0-24 hours

Secondary outcomes (13)

  1. Number of unformed stools

    Measured: 0-12, 12-24, 24-36, 36-48 hours

  2. Time to last unformed stool

    Measured: Throughout duration of the study

  3. Time to complete relief of abdominal discomfort

    Measured: Throughout duration of the study

  4. Time to complete relief of diarrhea

    Measured: Throughout duration of the study

  5. Proportion of subjects with complete relief of diarrhea

    Measured: 4, 8, 12, 24 and 48 hours

  6. Gas-related abdominal discomfort ratings - change from baseline at subsequent time points

    Measured: Throughout duration of the study

  7. Proportions of subjects with complete well-being

    Measured: at 12, 24 and 48 hours.

  8. Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief

    Measured: Throughout duration of the study

  9. Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study

    Measured: Throughout duration of the study

  10. Frequency of complete well-being following diarrhea illness

    Measured: at 7 days follow up

  11. Stool frequency

    Measured: at 7 days follow up

  12. Frequency of diarrhea relapse

    Measured: at 7 days follow up

  13. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.

    Measured: throughout duration of the study (+ 30 days for spontaneously-reported SAEs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00807326
Sponsor's protocol ID
LOPDIR4002
Status last verified
Jul 2012
First submitted
9 Dec 2008
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • Cottrell J, Koenig K, Perfekt R, Hofmann R; Loperamide-Simethicone Acute Diarrhoea Study Team. Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial. Drugs R D. 2015 Dec;15(4):363-73. doi: 10.1007/s40268-015-0111-y.

    PubMed 26541878

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Loperamide/simeticone 2 mg/125 mg caplets, Loperamide/simeticone 2 mg/125 mg chewable tablets and Probiotic Saccharomyces boulardii 250 mg capsules in people with Diarrhea, run by McNeil AB at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Mexico, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of unformed stools (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00807326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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