Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Novexel Inc
ClinicalTrials.gov Identifier:
NCT00653172
First received: April 1, 2008
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults


Condition Intervention Phase
Community Acquired Pneumonia
Drug: NXL103
Drug: comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults

Resource links provided by NLM:


Further study details as provided by Novexel Inc:

Primary Outcome Measures:
  • Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]
  • Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ] [ Designated as safety issue: Yes ]

Enrollment: 302
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NXL103
Drug: NXL103
500mg orally twice daily
Active Comparator: 3 Drug: comparator
comparator twice daily
Experimental: 2
NXL103
Drug: NXL103
600mg orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Community acquired pneumonia

Exclusion Criteria:

  • severe CAP
  • respiratory infections attributed to sources other than community acquired bacterial infection
  • concomitant pulmonary disease
  • history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653172

  Show 60 Study Locations
Sponsors and Collaborators
Novexel Inc
  More Information

No publications provided

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
Study First Received: April 1, 2008
Last Updated: January 8, 2009
Health Authority: Croatia: Ministry of Health and Social Care
Chile: Instituto de Salud Pública de Chile
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Novexel Inc:
CAP
community acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 21, 2014