Trial Outcomes & Findings for Treatment of Zollinger-Ellison Syndrome With Prevacid (NCT NCT00204373)

NCT ID: NCT00204373

Last Updated: 2012-10-30

Results Overview

number of participants with control of gastric acid production

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: up to 240 months from study enrollment
• Results posted on: 2012-10-30

Participant Flow

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.

The first phase of this study involved a short-term dose determination phase followed by a long-term treatment phase.

Participant milestones

Measure	Single Group 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 Study STARTED	72
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Zollinger-Ellison Syndrome With Prevacid

Baseline characteristics by cohort

Measure	Single Group n=72 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 240 months from study enrollment

number of participants with control of gastric acid production

Outcome measures

Measure	Single Group n=72 Participants 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.
Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.	72 participants

SECONDARY outcome

Timeframe: survival or up to 240 months

The median survival from the time of diagnosis

Outcome measures

Measure	Single Group n=72 Participants 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.
The Median Survival From the Time of Diagnosis.	6.6 years Standard Deviation 1.8

Adverse Events

Single Group

Serious events: 28 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Group n=72 participants at risk 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.
Gastrointestinal disorders Mucosal relapse	16.7% 12/72 • Number of events 12
Cardiac disorders Death	12.5% 9/72 • Number of events 9
Gastrointestinal disorders Cancer	6.9% 5/72 • Number of events 5
Gastrointestinal disorders Death (metastatic gastrinoma)	2.8% 2/72 • Number of events 2

Other adverse events

Measure	Single Group n=72 participants at risk 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.
Gastrointestinal disorders Nausea and vomiting	18.1% 13/72 • Number of events 13
Respiratory, thoracic and mediastinal disorders Pneumonia	5.6% 4/72 • Number of events 4
Musculoskeletal and connective tissue disorders Leg Pain	5.6% 4/72 • Number of events 4

Additional Information

Dr. C. Mel Wilcox

The University of Alabama at Birmingham

Phone: 205-934-6060

Email: melw@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place