Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis (AZI)
Gastroparesis
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Gastroparesis Treatment, Gastric Emptying, Prokinetic Agents, Macrolides, Erythromycin, Azithromycin, Erythromycin Cardiac Side-effects, Erythromycin drug interactions, AZI
Eligibility Criteria
Inclusion Criteria:
- presenting to gastroenterology motility specialty clinics at the University of Florida (UF), who meet the clinical and radiologic diagnostic criteria for diagnosis of GP
Exclusion Criteria:
- Any history of mechanical obstruction
- Gastrointestinal malignancy
- Current use of prokinetics such as cisapride, pimozide, or anticholinergic medication which cannot be discontinued 72 hrs prior to study
- Abnormal upper endoscopy with finding of erosions or ulcerations
- Helicobacter pylori infection in past 6 months
- Recent abdominal surgery < 6 months
- Cardiac history with EKG finding of QTC > 450 done on a screening test
- Detected renal or hepatic dysfunction described as a GFR <10 ml/min and ALT/AST values > 2 times the normal level in our laboratory
- Allergy to macrolide antibiotics
- Psychiatric history other than anxiety or depression
- Predominant symptoms of irritable bowel syndrome such as constipation or diarrhea
- Uncontrolled diabetes with fasting blood glucose levels > 180 mg/dL, due to effect of hyperglycemia on gastric emptying. For patients with diabetes, blood glucose levels will be recorded in a patient diary.
- Pregnant or nursing females
- Any history of myasthenia gravis
- Current use of Coumadin, lovastatin, simvastatin Nelfinavir, theophylline, digoxin, ergotamine/dihydroergotamine products, benzodiazepines, and sildenafil (this will be discontinued for the duration of the clinical trial if subject is on this medication).
- History of elevated liver function studies or CPKs.
- Pregnancy : A urine pregnancy test will be performed at the beginning of each treatment period and only subjects who are not pregnant will be enrolled for the study.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
erythromycin
Azithromycin
200mg/5ml elixir administered orally three times a day half an hour prior to meals.
The dose of Azithromycin was determined based on our dose response curve obtained on 10 healthy subjects who were given three different doses of Azithromycin, 50 mg, 100 mg and 133 mg and underwent breath testing to determine the gastric emptying half-time. These doses were determined based on a maximum safe dosage per day of Azithromycin of 400 mg given the medication would then be administered three times daily before meals. The appearance of the medication (azithromycin) and administration period was then identical to that of Erythromycin, i.e. 5ml elixir administered orally three times a day half an hour prior to meals. The total daily dosage of Azithromycin was determined after obtaining the dose- response analysis.