GoldBamboo.com - Knowledge is strong medicine
  

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 - Article


  Not Signed In - Sign In / Register


Get Your Free Credit Report Right Now!

Zip Code:






Strep Throat

 




Clinical Trial: 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

This study is no longer recruiting patients.

Sponsored by: Advancis Pharmaceutical Corporation
Information provided by: Advancis Pharmaceutical Corporation

Purpose

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).

Condition Treatment or Intervention Phase
Pharyngitis
Tonsillitis
 Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
Phase III

MedlinePlus related topics:  Streptococcal Infections;   Throat Disorders;   Tonsils/Tonsillectomy

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy 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

Further Study Details: 
Primary Outcomes: Bacteriological outcome at the Test of Cure Visit
Secondary Outcomes: Bacteriological outcome at the Late Post Therapy Visit; Clinical Outcome; Safety
Expected Total Enrollment:  500

Study start: October 2004;  Study completion: June 2005
Last follow-up: May 2005;  Data entry closure: May 2005

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Location Information


Utah
      Manford Gooch, MD, Salt Lake City,  Utah,  84121,  United States

More Information

Study ID Numbers:  111.301
Record last reviewed:  April 2005
Last Updated:  April 4, 2005
Record first received:  November 3, 2004
ClinicalTrials.gov Identifier:  NCT00095368
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $30 a year, a savings of 70% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Strep Throat.

November 25, 2009



Page Updated: October 15, 2009
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Health Forums

Copyright © 2004-2009 - Anaconda Partners LLC - All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.