PharyngitisPhase 3NCT00100126
APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat
A Phase 3 study testing Amoxicillin Pulsatile Release Multiparticluate Sprinkle in people with Pharyngitis, run by Advancis Pharmaceutical Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Amoxicillin Pulsatile Release Multiparticluate Sprinkle
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2004to Jun 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Give informed consent, assent, and documentation of patient authorization for disclosure of study results.
- Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.
- Age > = 6 months -12 years.
- A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:
- Tonsillar or pharyngeal exudate
- Tender cervical lymph nodes
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- Fever or history of fever treated with antipyretics
- Odynophagia
- Uvular edema
- Pharyngeal Erythema of moderate or greater intensity
- Elevated white blood cell (WBC) >12,000/mm3 or 10% bands
- Red tongue and prominent papillae (Strawberry tongue)
- A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A Test).
- Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms.
- Females must be non-lactating and:
- If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study.
Who cannot join
- Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.
- The need for hospitalization or I.V. antimicrobial therapy.
- Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials.
- Patients who are known carriers of S. pyogenes.
- Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials.
- Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:
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- Any rapidly progressive underlying disease with a shortened life expectancy.
- The inability to swallow the study dosage form.
- Unable to understand the requirements of the study.
- Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state.
- Hard chills or rigors.
- Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures.
- Psychiatric condition requiring use of major tranquilizers.
- Pregnancy or nursing.
- Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study.
- Current drug or alcohol abuse.
- Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period).
- Previous treatment under this protocol.
- Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days.
- Hospitalization within the month prior to study admission, during which antibacterial therapy was administered.
- The presence of clinically significant hematologic conditions or cardiac valvular disease.
- History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes.
- Probenecid treatment or systemic steroids during the duration of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Neuroscience Research
Salt Lake City, Utah, 84121
Study site
Simpsonville, South Carolina, 29681
About this study
Official title: A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes
The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.
- Conditions
- Pharyngitis
- Being tested
- Amoxicillin Pulsatile Release Multiparticluate Sprinkle
- Keywords
- Pharyngitis, Strep throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin Pulsatile Release Multiparticluate SprinkleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological outcome at Test of Cure Visit
Secondary outcomes (3)
Bacteriological outcome at Late Post Therapy Visit
Clinical Outcomes
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2004 (estimated)
- Study startDec 2004
- Study completionJun 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
- Single blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Advancis Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan Clausen, PhD, Study director, Advancis Pharmaceutical Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100126
- Sponsor's protocol ID
- 231.301
- Status last verified
- Apr 2005
- First submitted
- 23 Dec 2004
- Last updated
- 25 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes
- ClinicalTrials.gov ID
- NCT00100126
- Acronym / sponsor ID
- 231.301
- Conditions
- Pharyngitis
- Keywords
- Pharyngitis, Strep throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Advancis Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Jun 2005
- First posted
- 24 Dec 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 this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Give informed consent, assent, and documentation of patient authorization for disclosure of study results.
- Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.
- Age > = 6 months -12 years.
- A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:
- A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A Test).
Key exclusion criteria (23 listed)
- Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.
- Any rapidly progressive underlying disease with a shortened life expectancy.
- The inability to swallow the study dosage form.
- Unable to understand the requirements of the study.
- Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state.
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 Multiparticluate Sprinkle | Drug | – |
Primary outcome
Bacteriological outcome at Test of Cure Visit
3 secondary outcomes
Bacteriological outcome at Late Post Therapy Visit
Clinical Outcomes
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 25 Oct 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.
Susan Clausen, PhD study director
Advancis Pharmaceutical Corp
2 sites 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 Multiparticluate Sprinkle in people with Pharyngitis, run by Advancis Pharmaceutical Corporation at 2 sites 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 16 inclusion and 23 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 25 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 25 Oct 2006.