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A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis (PSC)

This study has been completed.
Sponsor:
Collaborator:
PSC Partners Seeking a Cure Foundation
Information provided by (Responsible Party):
Jayant A. Talwalkar, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01085760
First received: March 10, 2010
Last updated: July 12, 2013
Last verified: July 2013
History of Changes
Results First Received: November 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Sclerosing Cholangitis
Interventions: Drug: Vancomycin
Drug: Metronidazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 35 adult patients with primary sclerosing cholangitis (PSC) were enrolled between February 2010 and November 2011 at Mayo Clinic, Rochester MN.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Low Dose Vancomycin Vancomycin 125 mg 4 times a day
High Dose Vancomycin Vancomycin 250 mg 4 times a day
Low Dose Metronidazole Metronidazole 250 mg 3 times a day
High Dose Metronidazole metronidazole 500 mg 3 times a day

Participant Flow:   Overall Study
    Low Dose Vancomycin     High Dose Vancomycin     Low Dose Metronidazole     High Dose Metronidazole  
STARTED     8     9     9     9  
COMPLETED     7     8     7     6  
NOT COMPLETED     1     1     2     3  



  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
Low Dose Vancomycin Vancomycin 125 mg 4 times a day
High Dose Vancomycin Vancomycin 250 mg 4 times a day
Low Dose Metronidazole Metronidazole 250 mg 3 times a day
High Dose Metronidazole metronidazole 500 mg 3 times a day
Total Total of all reporting groups

Baseline Measures
    Low Dose Vancomycin     High Dose Vancomycin     Low Dose Metronidazole     High Dose Metronidazole     Total  
Number of Participants  
[units: participants]
 		  8     9     9     9     35  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     8     6     9     9     32  
>=65 years     0     3     0     0     3  
Age  
[units: years]
Median (Full Range) 		  40  
  (20 to 60)   		  42  
  (27 to 70)   		  35  
  (21 to 64)   		  40  
  (20 to 60)   		  40  
  (20 to 70)  
Gender  
[units: participants]
 		         
Female     4     9     4     4     21  
Male     4     0     5     5     14  
Region of Enrollment  
[units: participants]
 		         
United States     8     9     9     9     35  



  Outcome Measures
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1.  Primary:   Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment   [ Time Frame: baseline, 12 weeks ]
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2.  Secondary:   Change From Baseline in Total Bilirubin Following 12 Weeks Treatment   [ Time Frame: baseline, 12 weeks ]
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3.  Secondary:   Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment   [ Time Frame: baseline, 12 weeks ]
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4.  Secondary:   Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment   [ Time Frame: baseline, 12 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  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: Dr. Jayant A. Talwalkar
Organization: Mayo Clinic
phone: 507-538--4877
e-mail: talwalkar.jayant@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Jayant A. Talwalkar, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01085760     History of Changes
Other Study ID Numbers: 08-008247
Study First Received: March 10, 2010
Results First Received: November 2, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board