Acute Gastroenteritis in Adult TravelersPhase 3NCT00392574
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
A Phase 3 study testing Prulifloxacin in people with Acute Gastroenteritis in Adult Travelers, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gastroenteritis in Adult Travelers
- What is being tested?
- Prulifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2008
- Phase
- Phase 3
- 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 Bacterial Gastroenteritis;
- Traveler from Industrialized Country;
- Capable of giving Informed Consent
Who cannot join
- Fever (>100.3 degrees);
- Pregnant or Breast Feeding or Not using adequate birth control;
- Known or Suspected (co-)Infection with non-bacterial pathogen;
- Symptoms of Gastroenteritis of >72 hours;
- Bloody Diarrhea;
- Concomitant antibacterial with activity against enteric bacterial pathogens;
Show all 10Show fewer
- History of IBD;
- Unable/Unwilling to comply with study protocol;
- > 2 doses of anti-diarrheal medication within 24 hours;
- Antimicrobial Treatment within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
Read the detailed description
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.
- Conditions
- Acute Gastroenteritis in Adult Travelers
- Being tested
- Prulifloxacin, Placebo
- Keywords
- Gastroenteritis
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrulifloxacinDrug
Tablet
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Prulifloxacin Receives: Drug: Prulifloxacin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to last unformed stool
Measured: Study days 1-3
Secondary outcomes (2)
Clinical cure based on relief of signs and symptoms
Measured: Study days 1-3
Microbiologic eradication rates
Measured: Study days 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastroenteritis in Adult TravelersStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Dupont, MD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392574
- Sponsor's protocol ID
- OPT-099-001
- Status last verified
- Aug 2010
- First submitted
- 24 Oct 2006
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
- ClinicalTrials.gov ID
- NCT00392574
- Acronym / sponsor ID
- OPT-099-001
- Conditions
- Acute Gastroenteritis in Adult Travelers
- Keywords
- Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Oct 2006 (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.
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
Detailed description
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.
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: PrulifloxacinPrulifloxacin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Acute Bacterial Gastroenteritis;
- Traveler from Industrialized Country;
- Capable of giving Informed Consent
Key exclusion criteria (10 listed)
- Fever (>100.3 degrees);
- Pregnant or Breast Feeding or Not using adequate birth control;
- Known or Suspected (co-)Infection with non-bacterial pathogen;
- Symptoms of Gastroenteritis of >72 hours;
- Bloody Diarrhea;
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 |
|---|---|---|
| PrulifloxacinTablet | Drug | 1 |
| PlaceboTablet | Drug | 2 |
Primary outcome
Time to last unformed stool
Time frame: Study days 1-3
2 secondary outcomes
Clinical cure based on relief of signs and symptoms
Time frame: Study days 1-3
Microbiologic eradication rates
Time frame: Study days 1-3
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 15 May 2015.
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 Dupont, MD study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prulifloxacin in people with Acute Gastroenteritis in Adult Travelers, run by Merck Sharp & Dohme LLC at 1 site in United States.
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 3 inclusion and 10 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 15 May 2015. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to last unformed stool (time frame: Study days 1-3). 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 15 May 2015.