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Trial record 1 of 1 for:    LOFBO-LTSS-001
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A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection

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ClinicalTrials.gov Identifier: NCT00210639
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : May 23, 2011
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Musculoskeletal Diseases
Intervention Drug: No intervention
Enrollment 2233
Recruitment Details For this study, a total of 2233 participants were enrolled; 1620 participants from 2 otitis media studies (LOFBO-OTMD-001, LOFBO-OTMD-002) and 613 from a community acquired pneumonia study (LOFBIV-PCAP-003).
Pre-assignment Details Only 207 participants out of 2233 participants were required for yearly follow-up during the Musculoskeletal Disorder (MSD) follow-up phase.
Arm/Group Title Levofloxacin Comparator
Hide Arm/Group Description Participants who received levofloxacin in the previous studies. Participants who received comparator in the previous studies.
Period Title: Overall Study
Started 124 83
Completed 61 41
Not Completed 63 42
Reason Not Completed
Lost to Follow-up             37             29
Withdrawal by Subject             8             1
Other             18             12
Arm/Group Title Levofloxacin Comparator Total
Hide Arm/Group Description Participants who received levofloxacin in the previous studies. Participants who received comparator in the previous studies. Total of all reporting groups
Overall Number of Baseline Participants 124 83 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 83 participants 207 participants
3.9  (2.52) 3.5  (2.46) 3.7  (2.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 83 participants 207 participants
Female
48
  38.7%
40
  48.2%
88
  42.5%
Male
76
  61.3%
43
  51.8%
119
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants 83 participants 207 participants
ARGENTINA 16 11 27
BRAZIL 8 4 12
CHILE 10 12 22
COSTA RICA 27 15 42
ISRAEL 2 0 2
MEXICO 0 1 1
PANAMA 0 1 1
UNITED STATES 61 39 100
AgeCategorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants 83 participants 207 participants
<2 YEARS 16 14 30
2-<6 YEARS 95 62 157
6-<12 YEARS 9 5 14
12-<17 YEARS 4 2 6
1.Primary Outcome
Title Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
Hide Description The criteria used to assess Musculoskeletal Adverse Event is based on system organ class "Musculoskeletal and connective tissue disorders" of MedDRA 13.0.
Time Frame Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants (207) who were followed up during the MSD Follow-Up Phase.
Arm/Group Title Levofloxacin Comparator
Hide Arm/Group Description:
Participants who received levofloxacin in the previous studies.
Participants who received comparator in the previous studies.
Overall Number of Participants Analyzed 124 83
Measure Type: Number
Unit of Measure: Participants
3 3
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levofloxacin Comparator
Hide Arm/Group Description Participants who received levofloxacin in the previous studies. Participants who received comparator in the previous studies.
All-Cause Mortality
Levofloxacin Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Levofloxacin Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   2/124 (1.61%)   3/83 (3.61%) 
Gastrointestinal disorders     
Inguinal Hernia  1  1/124 (0.81%)  0/83 (0.00%) 
Infections and infestations     
Infectious Mononucleosis  1  1/124 (0.81%)  0/83 (0.00%) 
Otitis Media Chronic  1  0/124 (0.00%)  1/83 (1.20%) 
Surgical and medical procedures     
Surgery  1  0/124 (0.00%)  1/83 (1.20%) 
Tonsillectomy  1  0/124 (0.00%)  1/83 (1.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levofloxacin Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   3/124 (2.42%)   6/83 (7.23%) 
Injury, poisoning and procedural complications     
Upper Limb Fracture  1  0/124 (0.00%)  2/83 (2.41%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/124 (0.81%)  0/83 (0.00%) 
Bone Pain  1  1/124 (0.81%)  0/83 (0.00%) 
Hypermobility Syndrome  1  1/124 (0.81%)  0/83 (0.00%) 
Musculoskeletal Pain  1  1/124 (0.81%)  0/83 (0.00%) 
Synovitis  1  1/124 (0.81%)  0/83 (0.00%) 
Tendon Disorder  1  1/124 (0.81%)  0/83 (0.00%) 
Pain in Extremity  1  0/124 (0.00%)  1/83 (1.20%) 
Patellofemoral Pain Syndrome  1  0/124 (0.00%)  1/83 (1.20%) 
Nervous system disorders     
Spastic Paralysis  1  0/124 (0.00%)  1/83 (1.20%) 
Surgical and medical procedures     
Otoplasty  1  0/124 (0.00%)  1/83 (1.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
This was an observational safety study with no efficacy endpoints. Adverse event data is entered into the appropriate section within this submission.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
Phone: 1 609 730-3158
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210639    
Other Study ID Numbers: CR004171
LOFBO-LTSS-001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
PRI/LOF-INT-4 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: April 26, 2011
Results First Posted: May 23, 2011
Last Update Posted: April 21, 2014