Multiple Endocrine Neoplasia, Zollinger-Ellison Syndrome
Conditions
Brief summary
The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
Detailed description
The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.
Interventions
DRUGLansoprazole (Prevacid)
Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.
Sponsors
Takeda Pharmaceuticals North America, Inc.
Charles Mel Wilcox, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Zollinger-Ellison syndrome
Exclusion criteria
* Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment. | up to 240 months from study enrollment | number of participants with control of gastric acid production |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Median Survival From the Time of Diagnosis. | survival or up to 240 months | The median survival from the time of diagnosis |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Age Continuous | 54 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 72 |
| serious Total, serious adverse events | 28 / 72 |
Outcome results
Primary
Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
number of participants with control of gastric acid production
Time frame: up to 240 months from study enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Group | 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
The Median Survival From the Time of Diagnosis.
The median survival from the time of diagnosis
Time frame: survival or up to 240 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Single Group | The Median Survival From the Time of Diagnosis. | 6.6 years | Standard Deviation 1.8 |