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Trial record 1 of 1 for:    NCT00814333
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Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis

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ClinicalTrials.gov Identifier: NCT00814333
Recruitment Status : Terminated (Product supplier change - bought out. Unable to enroll patients.)
First Posted : December 24, 2008
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Keith Sale, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE December 23, 2008
First Posted Date  ICMJE December 24, 2008
Results First Submitted Date  ICMJE December 10, 2015
Results First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 15, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
Cessation of Epistaxis [ Time Frame: baseline, day 4-6 ]
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 Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Official Title  ICMJE A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Brief Summary Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epistaxis
Intervention  ICMJE
  • Drug: Thrombin-JMI
    5,000 IU, to nasal mucosa via syringe spray applicator
  • Drug: Merocel pack
    8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
Study Arms  ICMJE
  • Experimental: 1
    Thrombin-JMI
    Intervention: Drug: Thrombin-JMI
  • Active Comparator: 2
    Merocel pack
    Intervention: Drug: Merocel pack
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
1
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2008)
50
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital

Exclusion Criteria:

  • Non-english speaking patients
  • Patients with bleeding disorders
  • Known pregnant women or women that think they may be pregnant
  • Patients with a know presence of antibodies to bovine thrombin preparations
  • Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis
  • Patients found to have posterior epistaxis
  • Patients requiring a surrogate for medical decisions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00814333
Other Study ID Numbers  ICMJE 11564
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Sale, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Keith Sale, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date December 2015

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