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

This study has been terminated.
(Viokase was taken off market during study and remained off over a year.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01142128
First received: June 9, 2010
Last updated: February 20, 2013
Last verified: February 2013
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, 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

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Participants

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

Participant Flow:   Overall Study
    All Participants  
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  
Physician Decision                 1  
Lost to Follow-up                 1  
Withdrawal by Subject                 2  



  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
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
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
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
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 Total of all reporting groups

Baseline Measures
    Nexium Alone     Placebo to Nexium, Alone     Viokase 16 Plus Nexium     Viokase 16 Plus Placebo to Nexium     Total  
Number of Participants  
[units: participants]
  3     3     2     0     8  
Age  
[units: participants]
         
<=18 years     0     0     0         0  
Between 18 and 65 years     3     2     2         7  
>=65 years     0     1     0         1  
Gender  
[units: participants]
         
Female     1     2     1         4  
Male     2     1     1         4  
Region of Enrollment  
[units: participants]
         
United States     3     3     2         8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction of Abdominal Pain for Participants Taking Nexium Alone.   [ Time Frame: 4 months ]

2.  Primary:   Reduction of Abdominal Pain for Participants Taking Placebo to Nexium   [ Time Frame: 4 months ]

3.  Primary:   Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium   [ Time Frame: 4 months ]

4.  Primary:   Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  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:  
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:  
Name/Title: Phillip Toskes, M.D.
Organization: University of Florida
phone: 352-273-9493
e-mail: phillip.toskes@medicine.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01142128     History of Changes
Other Study ID Numbers: D.9612.L00058
Study First Received: June 9, 2010
Results First Received: October 19, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration