Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT01265550
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01265550
Study Brief:
Protocol Section:
NCT01265550