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Viokase 16, Viokase16 Plus Nexium and Nexium Alone (AZ)

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ClinicalTrials.gov Identifier: NCT01142128
Recruitment Status : Terminated (Viokase was taken off market during study and remained off over a year.)
First Posted : June 11, 2010
Results First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Pancreatitis
Interventions Drug: Nexium (esomeprazole magnesium)
Drug: Placebo to Nexium
Drug: Viokase 16 (pancrelipase) + Nexium
Drug: Viokase 16 + placebo to Nexium
Enrollment 12
Recruitment Details The dates of the recruitment period were February 2009 through January 2010. Subjects recruited at the University of Florida and the Shands Hospital. Recruited a total of 12 subjects. Enrollment was slow due to subjects not wanting to come off their medications, this was unanticipated.
Pre-assignment Details A total of 12 participants were consented to the study, however, 4 participants were never randomized to the study. Prior to randomization, subjects were off all enzymes and proton pump inhibitor's (PPI's) for 14 days.
Arm/Group Title All Participants
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Participants received one of four interventions in a randomized crossover design:

  1. Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
  2. Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
  3. Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
  4. Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Period Title: Overall Study
Started 8
Nexium Alone 3
Placebo to Nexium, Alone 3
Viokase 16 Plus Nexium 2
Viokase 16 Plus Placebo to Nexium 0
Completed 4
Not Completed 4
Reason Not Completed
Physician Decision             1
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Nexium Alone Placebo to Nexium, Alone Viokase 16 Plus Nexium Viokase 16 Plus Placebo to Nexium Total
Hide Arm/Group Description Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone Total of all reporting groups
Overall Number of Baseline Participants 3 3 2 0 8
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 2 participants 0 participants 8 participants
<=18 years 0 0 0 0
Between 18 and 65 years 3 2 2 7
>=65 years 0 1 0 1
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 2 participants 0 participants 8 participants
Female 1 2 1 4
Male 2 1 1 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 2 participants 0 participants 8 participants
3 3 2 8
1.Primary Outcome
Title Reduction of Abdominal Pain for Participants Taking Nexium Alone.
Hide Description To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be done due to the small sample size.
Arm/Group Title Nexium Alone
Hide Arm/Group Description:
Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Reduction of Abdominal Pain for Participants Taking Placebo to Nexium
Hide Description To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be done due to the small sample size.
Arm/Group Title Placebo to Nexium, Alone
Hide Arm/Group Description:
Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium
Hide Description To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be done due to the small sample size.
Arm/Group Title Viokase 16 Plus Nexium
Hide Arm/Group Description:
Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.
Hide Description To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be done due to the small sample size.
Arm/Group Title Viokase 16 Plus Placebo to Nexium
Hide Arm/Group Description:
Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from 03/02/2009 until 08/15/2010
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nexium Alone Placebo to Nexium, Alone Viokase 16 Plus Nexium Viokase 16 Plus Placebo to Nexium
Hide Arm/Group Description Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
All-Cause Mortality
Nexium Alone Placebo to Nexium, Alone Viokase 16 Plus Nexium Viokase 16 Plus Placebo to Nexium
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nexium Alone Placebo to Nexium, Alone Viokase 16 Plus Nexium Viokase 16 Plus Placebo to Nexium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)      0/2 (0.00%)      0/0    
Gastrointestinal disorders         
GI Pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/0  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nexium Alone Placebo to Nexium, Alone Viokase 16 Plus Nexium Viokase 16 Plus Placebo to Nexium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/3 (0.00%)      0/2 (0.00%)      0/0    
Hepatobiliary disorders         
Elevated Liver Enzymes  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Phillip Toskes, M.D.
Organization: University of Florida
Phone: 352-273-9493
EMail: phillip.toskes@medicine.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01142128     History of Changes
Other Study ID Numbers: D.9612.L00058
First Submitted: June 9, 2010
First Posted: June 11, 2010
Results First Submitted: October 19, 2012
Results First Posted: February 21, 2013
Last Update Posted: February 21, 2013