Acute Bacterial GastroenteritisPhase 3NCT00448422
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
A Phase 3 study testing prulifloxacin in people with Acute Bacterial Gastroenteritis, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in India.
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 patients with acute bacterial gastroenteritis (traveler's diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Gastroenteritis
- 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
- 268 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to Aug 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 an 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 acute gastroenteritis of >72 hours duration
- Bloody Diarrhea
- Concomitant antibacterial with activity against enteric bacterial pathogens
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- History of IBD
- Unable/Unwilling to comply with study protocol
- Greater than two doses of an antidiarrheal medication within 24 hours
- > 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 patients with acute bacterial gastroenteritis (traveler's diarrhea.
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 other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.
- Conditions
- Acute Bacterial Gastroenteritis
- Being tested
- prulifloxacin
- Keywords
- Traveler's, Diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prulifloxacinDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tablet Receives: Drug: prulifloxacin |
| 2 | Placebo comparator | Tablet Receives: Drug: prulifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Last Unformed Stool (TLUS)
Measured: End of Therapy
Secondary outcomes (2)
Microbiologic eradication rates
Measured: End of therapy/study
Clinical cure based on relief of signs and symptoms
Measured: End of therapy/study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial GastroenteritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Steffen, MD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448422
- Sponsor's protocol ID
- OPT-099-002
- Status last verified
- Sep 2010
- First submitted
- 15 Mar 2007
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. 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
- NCT00448422
- Acronym / sponsor ID
- OPT-099-002
- Conditions
- Acute Bacterial Gastroenteritis
- Keywords
- Traveler's, Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Mar 2007 (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 patients with acute bacterial gastroenteritis (traveler's diarrhea.
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 other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: prulifloxacinTablet |
| 2 | Placebo comparator | Drug: prulifloxacinTablet |
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 an industrialized country
- Capable of giving Informed Consent
Key exclusion criteria (11 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 acute gastroenteritis of >72 hours duration
- 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, 2 |
Primary outcome
Time to Last Unformed Stool (TLUS)
Time frame: End of Therapy
2 secondary outcomes
Microbiologic eradication rates
Time frame: End of therapy/study
Clinical cure based on relief of signs and symptoms
Time frame: End of therapy/study
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 27 Sep 2010.
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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.
Robert Steffen, MD study director
University of Zurich
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 Bacterial Gastroenteritis, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in India.
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 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 27 Sep 2010. 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 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. 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 (TLUS) (time frame: End of Therapy). 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 27 Sep 2010.