PharyngitisPhase 3NCT00095368
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
A Phase 3 study testing Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) in people with Pharyngitis and Tonsillitis, run by Advancis Pharmaceutical Corporation at 1 site in United States.
Trial summary
The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pharyngitis, Tonsillitis
- What is being tested?
- Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Give informed consent, assent and patient authorization
- Age 12 and over
- A clinical diagnosis of acute pharyngitis or tonsillitis
- A positive rapid Strep test
- Can swallow the oral study dosage forms
- Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active
Who cannot join
- Chronic or recurrent odynophagia
- Need for hospitalization or IV antimicrobial therapy
- Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
- Known carrier of S. pyogenes
- Allergies to penicillin or other beta-lactam antibiotics
- Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study
Show all 15Show fewer
- Seizure disorder
- Pregnant or nursing
- Expectation of additional systemic antibacterials would be required for another condition
- Current drug or alcohol abuse
- Any experimental drug or device within the last 30 days
- Prior systemic antibiotic therapy within the last 30 days
- Hospitalization within the last month which included antibacterial therapy
- The presence of clinically significant hematologic conditions, etc
- Probenecid treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).
- Conditions
- Pharyngitis, Tonsillitis
- Being tested
- Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
- Keywords
- Pharyngitis, Tonsillitis
- Medical subject headings
- Pharyngitis, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological outcome at the Test of Cure Visit
Secondary outcomes (3)
Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2004 (estimated)
- Study startOct 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies 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
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Advancis Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095368
- Sponsor's protocol ID
- 111.301
- Status last verified
- Apr 2005
- First submitted
- 3 Nov 2004
- Last updated
- 8 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
- ClinicalTrials.gov ID
- NCT00095368
- Acronym / sponsor ID
- 111.301
- Conditions
- Pharyngitis, Tonsillitis
- Keywords
- Pharyngitis, Tonsillitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Advancis Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- May 2005
- First posted
- 4 Nov 2004 (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 purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Give informed consent, assent and patient authorization
- Age 12 and over
- A clinical diagnosis of acute pharyngitis or tonsillitis
- A positive rapid Strep test
- Can swallow the oral study dosage forms
Key exclusion criteria (15 listed)
- Chronic or recurrent odynophagia
- Need for hospitalization or IV antimicrobial therapy
- Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
- Known carrier of S. pyogenes
- Allergies to penicillin or other beta-lactam antibiotics
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 |
|---|---|---|
| Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) | Drug | – |
Primary outcome
Bacteriological outcome at the Test of Cure Visit
3 secondary outcomes
Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety
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 8 Dec 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) in people with Pharyngitis and Tonsillitis, run by Advancis Pharmaceutical Corporation 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 6 inclusion and 15 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 8 Dec 2006. 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. 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?
Bacteriological outcome at the Test of Cure Visit. 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 8 Dec 2006; AzTrials last refreshed its copy on 6 Nov 2026.