Status:
COMPLETED
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
Lead Sponsor:
VA Office of Research and Development
Conditions:
GERD
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block g...
Eligibility Criteria
Inclusion
- Age 18-70 years
- History of heartburn (defined as a burning sensation in the retrosternal area of the chest) that is refractory to antisecretory medications
- Initial GERD-HRQL:
- Total score must be at least 6 and at least one of the six heartburn questions must be scored at least 2
- GERD-HRQL after two weeks of treatment with omeprazole:
- Total score must be \>50% of the initial GERD-HRQL score and at least one of the six heartburn questions must be scored at least 2
- Either or both of the following by baseline esophageal pH/multichannel intraluminal impedance (MII) monitoring in patients on omeprazole 20 mg two times a day (BID):
- Positive symptom association probability (SAP) (\>95%) for acid reflux, non-acid reflux or all reflux.
- Abnormal acid reflux (esophageal pH\<4 for at least 4.2% of the 24-hour monitoring period)
Exclusion
- Patients who do not have heartburn, defined as a burning sensation in the chest
- Patients unwilling or unable to provide informed consent
- Pregnancy or women unwilling to use effective contraception
- Age \<18 or \>70 years
- History of surgery on the stomach or esophagus
- History of seizure disorder
- History of heart block
- Allergy to or previous inability to tolerate study medications (omeprazole, baclofen, desipramine)
- Esophageal varices
- Cirrhosis
- Co-morbidity of sufficient severity to preclude elective surgery (e.g. pulmonary, cardiac, renal, liver disease)
- History of disorders that can cause medically-refractory "GERD symptoms" (eosinophilic esophagitis, neoplasms of the upper gastrointestinal tract, gastroparesis, achalasia)
- Myocardial infarction within the past 6 months
- History of schizophrenia
- Current use of clopidogrel
- Patients who have a contraindication to omeprazole or baclofen or who require therapy with a medication that has a clinically important drug interaction with omeprazole or baclofen.
- Patients who, in the judgment of the PI, are not suitable candidates for therapy with a study medication (omeprazole, baclofen, desipramine)
- Initial GERD-HRQL score: Total score \<6 and/or all heartburn scores \<2
- Inability to tolerate omeprazole during the 2-week treatment phase (before randomization)
- GERD-HRQL after two weeks of treatment with omeprazole: Total score less than or equal to 50% of initial GERD-HRQL score and/or all heartburn scores \<2
- Laboratory abnormalities including:
- Platelet count \<100,000
- international normalized ratio (INR) \>1.5 (off anticoagulants)
- Serum creatinine \>2.0 mg per deciliter
- Endoscopic abnormalities including:
- Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
- Active ulceration of the esophagus that is not due to reflux esophagitis
- Candida esophagitis
- Esophageal varices
- Active ulceration of the stomach and/or duodenum
- Neoplasm of the esophagus, stomach or duodenum
- Gastric outlet obstruction
- Eosinophilic esophagitis at least (15 eosinophils per high power field in any esophageal biopsy specimen)
- Manometric abnormalities including:
- Achalasia
- Complete aperistalsis
- Negative SAP ( 95%) for acid reflux, non-acid reflux and all reflux on baseline combined esophageal pH/MII monitoring and normal acid reflux (esophageal pH\<4 for \<4.2% of the 24-hour monitoring period)
- Study surgeon identifies a contraindication to laparoscopic Nissen fundoplication
- Morbid obesity (BMI at least 40)
- Large paraesophageal hernia
Key Trial Info
Start Date :
August 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2016
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT01265550
Start Date
August 13 2012
End Date
December 30 2016
Last Update
January 22 2020
Active Locations (15)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
2
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723
3
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
4
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822