Chronic BronchitisPhase 3NCT00255983
A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
A Phase 3 study testing Faropenem medoxomil in people with Chronic Bronchitis, run by Replidyne at 1 site in United States.
Trial summary
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- Faropenem medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation
Who cannot join
- Gold criteria III
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.
Read the detailed description
This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.
- Conditions
- Chronic Bronchitis
- Being tested
- Faropenem medoxomil, placebo
- Keywords
- bronchitis, AECB
- Medical subject headings
- Bronchitis, Chronic, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faropenem medoxomilDrug
600 mg BID for 5 days
placeboDrug
placebo tablets BID for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | faropenem medoxomil Receives: Drug: Faropenem medoxomil |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Clinical response at test of cure.
Measured: Day 8 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionJun 2008 (estimated)
Why it stopped: financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Replidyne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Investigators
- Roger M Echols, MD, Study director, Replidyne, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255983
- Sponsor's protocol ID
- REP-FAR-005
- Status last verified
- May 2008
- First submitted
- 16 Nov 2005
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00255983
- Acronym / sponsor ID
- REP-FAR-005
- Conditions
- Chronic Bronchitis
- Keywords
- bronchitis, AECB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: financial reasons
- Enrolment
- 491 participants (actual)
- Lead sponsor
- ReplidyneIndustry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (estimated)
- First posted
- 21 Nov 2005 (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.
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.
Detailed description
This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.
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: Faropenem medoxomilfaropenem medoxomil |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation
Key exclusion criteria (1 listed)
- Gold criteria III
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 |
|---|---|---|
| Faropenem medoxomil600 mg BID for 5 days | Drug | 1 |
| placeboplacebo tablets BID for 5 days | Drug | 2 |
Primary outcome
• Clinical response at test of cure.
Time frame: Day 8 to 12
Results and safety
The study was stopped early (reason given: financial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
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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.
Roger M Echols, MD study director
Replidyne, Inc.
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 Faropenem medoxomil in people with Chronic Bronchitis, run by Replidyne 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Jun 2008. 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 was stopped early (reason given: financial reasons). Results are not available in the source record.
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?
• Clinical response at test of cure. (time frame: Day 8 to 12). 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 3 Jun 2008.