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Low Back Pain and Antibiotic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00285493
Recruitment Status : Withdrawn (Withdrawn: study halted prematurely, prior to enrollment of first participant)
First Posted : February 2, 2006
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
Clalit Health Services
Information provided by:
Loewenstein Hospital

Tracking Information
First Submitted Date  ICMJE February 1, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date March 13, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
protocol designed to assess or examine persons or groups in a systematic way to identify specific markers for eligibility for further evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Back Pain and Antibiotic Treatment
Official Title  ICMJE Phase 1 Study of Antibiotic Treatment for Low Back Pain
Brief Summary Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.
Detailed Description Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE Drug: Antibiotics
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 12, 2014)
0
Original Enrollment  ICMJE
 (submitted: February 1, 2006)
50
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Must be able to swallow tablets

Exclusion Criteria:

- Allergy to antibiotics

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Israel
 
Administrative Information
NCT Number  ICMJE NCT00285493
Other Study ID Numbers  ICMJE 230859
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Loewenstein Hospital
Collaborators  ICMJE Clalit Health Services
Investigators  ICMJE
Study Director: Bambi Alyagon, MSc Loewenstein Hospital
Principal Investigator: Shoshana Weiler, MD Loewenstein Hospital
PRS Account Loewenstein Hospital
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP