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Sore ThroatPhase 3NCT00242281

APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat

A Phase 3 study testing APC-111 MP Tablet, 775 mg in people with Sore Throat and Pharyngitis, run by Advancis Pharmaceutical Corporation at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Sore Throat, Pharyngitis, Tonsillitis
What is being tested?
APC-111 MP Tablet, 775 mg
Type of treatment
Pill or oral medicine
How many people
600 participants
Where
41 sitesin 2 countries
Study dates
Nov 2005to Jul 2006
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

  • Informed consent/assent
  • Age 12 and older
  • 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 and pharyngeal erythema with at least one of the following:
  • Odynophagia
  • Tonsillar or pharyngeal exudates
  • Tender cervical lymph nodes
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  • Fever or history of fever treated with antipyretics
  • Chills
  • Uvular edema
  • Elevated white blood cell count
  • Red tongue and prominent papillae
  • A positive rapid screening test for S. pyogenes
  • Subject is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms
  • Females must be non-lactating and:
  • At no risk of pregnancy for one of the following reasons: post-menopausal for at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR
  • If of child-bearing potential and sexually active, the patient must have a negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study.
  • If of child bearing potential and not currently sexually active, the patient must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception.
  • Are able to comply with the requirements of the protocol

Who cannot join

  • Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology
  • More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit
  • Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials
  • Subjects who are known carriers of S. pyogenes
  • Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins
  • 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 immunocompromised state.
  • Concurrent condition of upper/lower respiratory tract infections
  • Concurrent symptoms of viral etiology including:
  • conjunctivitis, coryza, and cough
  • diffuse adenopathy or rash suggestive of mononucleosis
  • rash or arthropathy suggestive of scarlet fever
  • Seizure disorder, lowered seizure threshold, or 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
  • Previous treatment under this protocol
  • The need for hospitalization or I.V. antimicrobial therapy
  • Previous systemic antimicrobial therapy within 30 days
  • The presence of clinically significant hematologic conditions
  • History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes or previous rheumatic fever
  • Probenecid treatment or systemic steroids for 7 days prior to baseline visit and throughout the duration of the study

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

United States35 sites

  • Study site

    Bardstown, Kentucky

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Bountiful, Utah

  • Study site

    Bristol, Tennessee

  • Study site

    Burlington, North Carolina

  • Study site

    Butte, Montana

  • Study site

    Canfield, Ohio

  • Study site

    Carmichael, California

  • Study site

    Conyers, Georgia

  • Study site

    DeLand, Florida

  • Study site

    Edmonds, Washington

  • Study site

    Johnson City, New York

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kingsport, Tennessee

  • Study site

    Laguna Niguel, California

  • Study site

    Littleton, Colorado

  • Study site

    Milford, Massachusetts

  • Study site

    New Bedford, Massachusetts

  • Study site

    Newport News, Virginia

  • Study site

    North Wales, Pennsylvania

  • Study site

    Omaha, Nebraska

  • Study site

    Overland Park, Kansas

  • Study site

    Phoenix, Arizona

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Luis Obispo, California

  • Study site

    Scotland, Pennsylvania

  • Study site

    Shippensburg, Pennsylvania

  • Study site

    Simpsonville, North Carolina

  • Study site

    Tallassee, Alabama

  • Study site

    Topeka, Kansas

  • Study site

    Wenatchee, Washington

  • Study site

    West Jordan, Utah

  • Study site

    Wichitia, Kansas

Other trials in United States

Canada6 sites

  • Study site

    Coquitlam, British Columbia

  • Study site

    Fort Erie, Ontario

  • Study site

    Markham, Ontario

  • Study site

    Saint-Jermone, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults

The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.

Being tested
APC-111 MP Tablet, 775 mg
Keywords
Sore Throat, 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.

  • APC-111 MP Tablet, 775 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)

Secondary outcomes (3)

  1. The bacteriological outcome at the Late Post Therapy visit (Day 38-45)

  2. Clinical Outcome at TOC and LPT

  3. Safety

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2005 (estimated)
  2. Study startNov 2005
  3. Study completionJul 2006

Resources

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
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00242281
Sponsor's protocol ID
111.302
Status last verified
Jan 2006
First submitted
18 Oct 2005
Last updated
25 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APC-111 MP Tablet, 775 mg in people with Sore Throat and Pharyngitis, run by Advancis Pharmaceutical Corporation at 41 sites in 2 countries.

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 18 inclusion and 26 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 41 sites in United States, Canada. 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?

The bacteriological outcome at the Test - of - Cure Visit (Day 14-18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00242281.

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.

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