DiarrheaPhase 4NCT00685607
Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea
A Phase 4 study testing loperamide-simethicone in people with Diarrhea, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- loperamide-simethicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Oct 2008
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea
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).
- Conditions
- Diarrhea
- Being tested
- loperamide-simethicone, matching placebo
- Keywords
- Pilot Study, Outcome Measures
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loperamide-simethiconeDrug
Also called Imodium
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.
matching placeboDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | loperamide-simethicone Receives: Drug: loperamide-simethicone |
| 2 | Placebo comparator | matching placebo Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Multiple Endpoints
Measured: 6 hours
Secondary outcomes (6)
Time to improvement in stool form
Measured: 6 hours
Time to improvement in urge to defecate
Measured: 6 hours
Time to improvement in gas-related abdominal discomfort
Measured: 6 hours
Time to improvement of change in normal activities of daily living
Measured: 6 hours
Subject global impression of efficacy of study medication at the end of the treatment period
Measured: 6 hours
Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert L DuPont, MD, Study chair, Department of Public Health, University of Texas, Houston School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685607
- Sponsor's protocol ID
- LOPDIR4003
- Status last verified
- Oct 2011
- First submitted
- 23 May 2008
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea
- ClinicalTrials.gov ID
- NCT00685607
- Acronym / sponsor ID
- LOPDIR4003
- Conditions
- Diarrhea
- Keywords
- Pilot Study, Outcome Measures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: loperamide-simethiconeloperamide-simethicone |
| 2 | Placebo comparator | Drug: matching placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loperamide-simethiconeAlso: ImodiumFour 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. | Drug | 1 |
| matching placeboAlso: PlaceboFour 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. | Drug | 2 |
Primary outcome
Evaluate Multiple Endpoints
Time frame: 6 hours
6 secondary outcomes
Time to improvement in stool form
Time frame: 6 hours
Time to improvement in urge to defecate
Time frame: 6 hours
Time to improvement in gas-related abdominal discomfort
Time frame: 6 hours
Time to improvement of change in normal activities of daily living
Time frame: 6 hours
Subject global impression of efficacy of study medication at the end of the treatment period
Time frame: 6 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert L DuPont, MD study chair
Department of Public Health, University of Texas, Houston School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing loperamide-simethicone in people with Diarrhea, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Mexico.
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 4 inclusion and 6 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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. Some participants in this study may receive a placebo. 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?
Evaluate Multiple Endpoints (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2011.