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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been terminated.
(lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205049
First Posted: September 20, 2005
Last Update Posted: May 13, 2014
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
Results First Submitted: August 4, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis, Alcoholic
Intervention: Drug: pentoxifylline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pentoxifylline All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Placebo All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days

Participant Flow:   Overall Study
    Pentoxifylline   Placebo
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pentoxifylline All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Placebo All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Total Total of all reporting groups

Baseline Measures
   Pentoxifylline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   Survival at 28 Days   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated before any data was gathered/analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Research Program Manager - Kelly Richie
Organization: University of Wisconsin
phone: 608-262-5404
e-mail: kr2@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205049     History of Changes
Other Study ID Numbers: M-2004-0388
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: August 4, 2011
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014