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Trial record 8 of 63 for:    "Bile Duct Disease" | "Anti-Infective Agents"

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

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ClinicalTrials.gov Identifier: NCT01085760
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : September 19, 2013
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
PSC Partners Seeking a Cure Foundation
Information provided by (Responsible Party):
Jayant A. Talwalkar, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis
Interventions Drug: Vancomycin
Drug: Metronidazole
Enrollment 35
Recruitment Details 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  
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description Vancomycin 125 mg 4 times a day Vancomycin 250 mg 4 times a day Metronidazole 250 mg 3 times a day metronidazole 500 mg 3 times a day
Period Title: Overall Study
Started 8 9 9 9
Completed 7 8 7 6
Not Completed 1 1 2 3
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole Total
Hide Arm/Group Description Vancomycin 125 mg 4 times a day Vancomycin 250 mg 4 times a day Metronidazole 250 mg 3 times a day metronidazole 500 mg 3 times a day Total of all reporting groups
Overall Number of Baseline Participants 8 9 9 9 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 9 participants 9 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
6
  66.7%
9
 100.0%
9
 100.0%
32
  91.4%
>=65 years
0
   0.0%
3
  33.3%
0
   0.0%
0
   0.0%
3
   8.6%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 9 participants 9 participants 35 participants
40
(20 to 60)
42
(27 to 70)
35
(21 to 64)
40
(20 to 60)
40
(20 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 9 participants 9 participants 35 participants
Female
4
  50.0%
9
 100.0%
4
  44.4%
4
  44.4%
21
  60.0%
Male
4
  50.0%
0
   0.0%
5
  55.6%
5
  55.6%
14
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 9 participants 9 participants 35 participants
8 9 9 9 35
1.Primary Outcome
Title Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment
Hide Description [Not Specified]
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was based on a per protocol analysis.
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description:
Vancomycin 125 mg 4 times a day
Vancomycin 250 mg 4 times a day
Metronidazole 250 mg 3 times a day
Metronidazole 500 mg 3 times a day
Overall Number of Participants Analyzed 7 8 7 6
Median (Full Range)
Unit of Measure: U/L
-117
(-304 to 165)
-49
(-315 to 18)
-62
(-502 to 212)
-36
(-450 to 42)
2.Secondary Outcome
Title Change From Baseline in Total Bilirubin Following 12 Weeks Treatment
Hide Description [Not Specified]
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis done
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description:
Vancomycin 125 mg 4 times a day
Vancomycin 250 mg 4 times a day
Metronidazole 250 mg 3 times a day
Metronidazole 500 mg 3 times a day
Overall Number of Participants Analyzed 7 8 7 6
Median (Full Range)
Unit of Measure: mg/dl
-0.4
(-0.9 to 0.2)
0.05
(-0.8 to 9.7)
-0.3
(-0.5 to 0)
0.05
(-0.5 to 0.4)
3.Secondary Outcome
Title Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment
Hide Description The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) – 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description:
Vancomycin 125 mg 4 times a day
Vancomycin 250 mg 4 times a day
Metronidazole 250 mg 3 times a day
Metronidazole 500 mg 3 times a day
Overall Number of Participants Analyzed 7 8 7 6
Median (Full Range)
Unit of Measure: units on a scale
-0.65
(-1.13 to 0.21)
-0.01
(-0.71 to 1.15)
-0.26
(-0.75 to 0.09)
-0.20
(-0.64 to 0.09)
4.Secondary Outcome
Title Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment
Hide Description [Not Specified]
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis done
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description:
Vancomycin 125 mg 4 times a day
Vancomycin 250 mg 4 times a day
Metronidazole 250 mg 3 times a day
Metronidazole 500 mg 3 times a day
Overall Number of Participants Analyzed 7 8 7 6
Median (Full Range)
Unit of Measure: mg/L
-2.2
(-47.3 to 0)
1
(-5.6 to 28.6)
-3.6
(-17.4 to 0)
0
(-1.9 to 2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Hide Arm/Group Description Vancomycin 125 mg 4 times a day Vancomycin 250 mg 4 times a day Metronidazole 250 mg 3 times a day metronidazole 500 mg 3 times a day
All-Cause Mortality
Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Vancomycin High Dose Vancomycin Low Dose Metronidazole High Dose Metronidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      3/9 (33.33%)      6/9 (66.67%)      8/9 (88.89%)    
Eye disorders         
burning in eyes   0/8 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders         
diarrhea   1/8 (12.50%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1
nausea   0/8 (0.00%)  0 1/9 (11.11%)  1 1/9 (11.11%)  1 6/9 (66.67%)  6
anorexia   0/8 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 2/9 (22.22%)  2
metallic taste   0/8 (0.00%)  0 0/9 (0.00%)  0 2/9 (22.22%)  2 2/9 (22.22%)  2
stomach pain   0/8 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 1/9 (11.11%)  1
dry mouth   0/8 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
General disorders         
increased fatigue   0/8 (0.00%)  0 1/9 (11.11%)  1 1/9 (11.11%)  1 1/9 (11.11%)  1
malaise   0/8 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Hepatobiliary disorders         
increased bilirubin   0/8 (0.00%)  0 2/9 (22.22%)  2 0/9 (0.00%)  0 0/9 (0.00%)  0
Metabolism and nutrition disorders         
weight loss   0/8 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders         
numbness and tingling of extremities   1/8 (12.50%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 3/9 (33.33%)  3
vertigo   1/8 (12.50%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
headaches   1/8 (12.50%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders         
increased itching   1/8 (12.50%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jayant A. Talwalkar
Organization: Mayo Clinic
Phone: 507-538--4877
EMail: talwalkar.jayant@mayo.edu
Layout table for additonal information
Responsible Party: Jayant A. Talwalkar, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01085760     History of Changes
Other Study ID Numbers: 08-008247
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: November 2, 2012
Results First Posted: September 19, 2013
Last Update Posted: September 19, 2013