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Trial record 8 of 49 for:    Zollinger-Ellison syndrome

Treatment of Zollinger-Ellison Syndrome With Prevacid

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.
 
ClinicalTrials.gov Identifier: NCT00204373
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : October 19, 2012
Last Update Posted : October 30, 2012
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Zollinger-Ellison Syndrome
Multiple Endocrine Neoplasia
Intervention Drug: Lansoprazole (Prevacid)
Enrollment 72
Recruitment Details Patients were recruited from the GI/Hepatology clinic located at The Kirklin Clinic. Patients were referred here from their primary care physician or chose this clinic through self-referral for care for a GI issue. Patients were recruited between early 2003 and early 2010.
Pre-assignment Details The first phase of this study involved a short-term dose determination phase followed by a long-term treatment phase.
Arm/Group Title Single Group
Hide Arm/Group Description This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Period Title: Overall Study
Started 72
Completed 72
Not Completed 0
Arm/Group Title Single Group
Hide Arm/Group Description This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<=18 years
0
   0.0%
Between 18 and 65 years
68
  94.4%
>=65 years
4
   5.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
54  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
30
  41.7%
Male
42
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
1.Primary Outcome
Title Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
Hide Description number of participants with control of gastric acid production
Time Frame up to 240 months from study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Group
Hide Arm/Group Description:
This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: participants
72
2.Secondary Outcome
Title The Median Survival From the Time of Diagnosis.
Hide Description The median survival from the time of diagnosis
Time Frame survival or up to 240 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Group
Hide Arm/Group Description:
This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Overall Number of Participants Analyzed 72
Median (Standard Deviation)
Unit of Measure: years
6.6  (1.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Group
Hide Arm/Group Description This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
All-Cause Mortality
Single Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Group
Affected / at Risk (%) # Events
Total   28/72 (38.89%)    
Cardiac disorders   
Death  [1]  9/72 (12.50%)  9
Gastrointestinal disorders   
Mucosal relapse  [2]  12/72 (16.67%)  12
Cancer  [3]  5/72 (6.94%)  5
Death (metastatic gastrinoma)  [4]  2/72 (2.78%)  2
Indicates events were collected by systematic assessment
[1]
The most common cause of death was cardiovascular disease or stroke (9 pts).
[2]
Mucosal relapse was documented in 12 pts (16.7%). The type or relapse included a peptic ulcer in 4.2% (0 gastric, 3 duodenal), reflux oesophagitis in 8 (11.1%) and small bowel perforation in 2 (2.8%).
[3]
5 patients developed cancer including pancreatic, gallbladder and lung cancers.
[4]
Two patients died due to progressive metastatic gastrinoma.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Group
Affected / at Risk (%) # Events
Total   21/72 (29.17%)    
Gastrointestinal disorders   
Nausea and vomiting   13/72 (18.06%)  13
Musculoskeletal and connective tissue disorders   
Leg Pain  [1]  4/72 (5.56%)  4
Respiratory, thoracic and mediastinal disorders   
Pneumonia   4/72 (5.56%)  4
Indicates events were collected by systematic assessment
[1]
4 patients experienced leg pain.
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: Dr. C. Mel Wilcox
Organization: The University of Alabama at Birmingham
Phone: 205-934-6060
EMail: melw@uab.edu
Layout table for additonal information
Responsible Party: Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00204373     History of Changes
Other Study ID Numbers: F030107005
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: May 16, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 30, 2012